Trial Outcomes & Findings for Fractionated Gemtuzumab Ozogamicin Followed by Non-engraftment Donor Leukocyte Infusions for Relapsed/Refractory Acute Myeloid Leukemia (NCT NCT03374332)
NCT ID: NCT03374332
Last Updated: 2026-07-23
Results Overview
The MTD of non-engraftment donor leukocyte infusions administered with fractionated gemtuzumab ozogamicin in patients with relapsed/refractory AML is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs. The recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) was evaluated by utilizing a 3+3 design to determine if 1-2x108 CD3 cells/kg can be safely administered with fractionated Gemtuzumab Ozogamicin administered on days 1,4 and 7 (total dose capped at 13.5 mg). The leukocyte infusion is administered on day 8 after completion of GO day 7. Two DLI dose levels well be assessed: DLI Dose Level 1: 1-2x107 CD3+ cells/kg DLI Dose Level 2: 1-2x108 CD3+ cells/kg The RP2D/MTD is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs through 35 days post DLI.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
11 participants
Primary outcome timeframe
35 days post infusion
Results posted on
2026-07-23
Participant Flow
Participant milestones
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
4
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Overall Study
Death
|
0
|
0
|
1
|
|
Overall Study
No DLI
|
0
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Total
n=11 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=11 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=11 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=11 Participants
|
|
Age, Continuous
|
71 years
n=3 Participants
|
64 years
n=4 Participants
|
73 years
n=4 Participants
|
68 years
n=11 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=11 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=11 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 Participants
n=3 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=11 Participants
|
PRIMARY outcome
Timeframe: 35 days post infusionThe MTD of non-engraftment donor leukocyte infusions administered with fractionated gemtuzumab ozogamicin in patients with relapsed/refractory AML is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs. The recommended phase 2 dose (RP2D) or maximum tolerated dose (MTD) was evaluated by utilizing a 3+3 design to determine if 1-2x108 CD3 cells/kg can be safely administered with fractionated Gemtuzumab Ozogamicin administered on days 1,4 and 7 (total dose capped at 13.5 mg). The leukocyte infusion is administered on day 8 after completion of GO day 7. Two DLI dose levels well be assessed: DLI Dose Level 1: 1-2x107 CD3+ cells/kg DLI Dose Level 2: 1-2x108 CD3+ cells/kg The RP2D/MTD is determined by the dose level achieved with no Dose limiting toxicities. Measure = participants without DLTs through 35 days post DLI.
Outcome measures
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3 Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Phase 1: Determine the RP2D or MTD of Nonengraftment Donor Leukocyte Infusions With Fractionated Gemtuzumab Ozogamicin in Patients With Relapsed/Refractory AML Defined as Dose Level Without Dose Limiting Toxicities.
|
3 Participants
|
4 Participants
|
—
|
PRIMARY outcome
Timeframe: 4 weeks post infusionResponse rate of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. Bone Marrow Biopsy to be done in patients thought to have responded. Complete remission or complete remission with incomplete count recovery, after one cycle of treatment. Rationale for including CRi: CRi has previously been used in gemtuzumab ozogamicin trials because of incomplete platelet recovery seen with this drug.
Outcome measures
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3 Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Response Rate
Progressive Disease
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Response Rate
Complete Response
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 2 years post end of treatmentPopulation: Zero participants met the objective for progression free survival at 2 years.
Progression free survival of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia.
Outcome measures
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3 Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Number of Participants Reaching 24 Months Progression Free Survival
Progression Free Survival
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through 2 years post end of treatmentPopulation: Zero participants met the objective for overall survival at 2 years
Overall survival of infusional gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia.
Outcome measures
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3 Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Number of Participants Who Met the Objective for Overall Survival at 2 Years
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Start of treatment through 30 days post the final infusionPopulation: DLT's were assessed in the two dose levels in Phase 1. The last arm was the Phase 2 arm.
Number of participants with dose limiting toxicities following treatment with gemtuzumab ozogamicin followed by nonengraftment donor leukocyte infusions in patients with refractory acute myeloid leukemia. DLT's defined in the protocol as * IBMTR Severity Index C \& D graft versus host disease * Grade 3 or 4 infusion related reaction * Any grade 3 non-hematological toxicities not directly resulting from patient's disease (with some exclusions specified in the protocol) * Any grade 4 related or unrelated non-hematological toxicity not directly resulting from patient's disease * Development of SOS * Discontinuation of treatment due to an adverse event of any grade is considered a DLT unless the AE is clearly and solely related to the underlying disease. All Grade 5 toxicities are considered DLTs unless clearly and solely related to the underlying disease.
Outcome measures
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 Participants
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3 Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Number of Participants With Dose Limiting Toxicities as Defined by the Protocol
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
Serious events: 3 serious events
Other events: 3 other events
Deaths: 3 deaths
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
Serious events: 2 serious events
Other events: 4 other events
Deaths: 4 deaths
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
Serious events: 3 serious events
Other events: 3 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Meningitis
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Localized edema
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Disease Progression
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Sepsis
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Multi-organ Failure
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Nervous system disorders
Syncope
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
Other adverse events
| Measure |
Phase 1 Treatment 1: Gemtuzumab Ozogamicin and DLI Dose Level 1
n=3 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^7 CD3+ cells and maximum of 2x10\^7 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 1 Treatment 2: Gemtuzumab Ozogamicin and DLI Dose Level 2
n=4 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
Phase 2 Treatment 3: Gemtuzumab Ozogamicin and DLI Dose Level 2 (MTD as Determined by Phase 1)
n=4 participants at risk
Day 8: The product will be administered unprocessed on day 8 (same day as leukapheresis) with a minimum of 1x10\^8 CD3+ cells and maximum of 2x10\^8 CD3+ cells/kg irrespective of the number of CD34+ cells.
Patients who show a transient response to therapy can receive up to two additional donor leukocyte infusions with GO 6mg/m2 (2mg/m2 each day, capped at 4.5mg) for all patients regardless of age administered on days 1,4, and 7, no sooner than 35 days status post their last cellular infusion.
Gemtuzumab Ozogamicin (GO): Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
Donor Leukocytes: The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Blood and lymphatic system disorders
Febrile Neutropenia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Ear and labyrinth disorders
Bilateral Ear Fullness
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Ear and labyrinth disorders
Hearing Impaired
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Dry Mouth
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Melena
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Mucositis Oral
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Oral Hemorrhage
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Chills
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Edema
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Fatigue
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Fever
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Immune system disorders
Cytokine Release Syndrome
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Abdominal Infection
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
General disorders
Malaise
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Enterocolitis Infectious
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Fungemia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Mucosal Infection
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Thrush
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Alanine aminotransferase increased
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Infections and infestations
Aspartate aminotransferase increased
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Blood bilirubin increased
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Blood lactate dehydrogenase increased
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Creatinine increased
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
100.0%
4/4 • Number of events 4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Lymphocyte count increased
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Neutrophil count decreased
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
Platelet count decreased
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Investigations
White blood cell decreased
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
75.0%
3/4 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
100.0%
4/4 • Number of events 4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
100.0%
3/3 • Number of events 3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
50.0%
2/4 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Obesity
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Metabolism and nutrition disorders
Tumor Lysis Syndrome
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Nervous system disorders
Headache
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Psychiatric disorders
Anxiety
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Psychiatric disorders
Insomnia
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Renal and urinary disorders
Hematuria
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Renal and urinary disorders
Urinary Frequency
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Renal and urinary disorders
Urinary Urgency
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Reproductive system and breast disorders
Genital Edema
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore Throat
|
33.3%
1/3 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Respiratory, thoracic and mediastinal disorders
Voice Alteration
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Vascular disorders
Hypertension
|
66.7%
2/3 • Number of events 2 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
|
Vascular disorders
Hypotension
|
0.00%
0/3 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
0.00%
0/4 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
25.0%
1/4 • Number of events 1 • All-Cause Mortality was assessed up to two years; Toxicity assessment to be done 30 days (+1 week) post last infusion (DLI or GO whichever is last), up to one year; SAEs post 30 days are still to be reported if suspected to be related to leukocyte infusion or GO, up to two years.
|
Additional Information
John Reagan, MD
Brown University Oncology Research Group (BrUOG)
Phone: 401-863-3000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place