Trial Outcomes & Findings for Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant (NCT NCT00068718)
NCT ID: NCT00068718
Last Updated: 2020-01-31
Results Overview
Percentage of Participants with Grade IV Acute GVHD
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
35 participants
Primary outcome timeframe
100 days after DLI
Results posted on
2020-01-31
Participant Flow
Participant milestones
| Measure |
Treatment (DLI)
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Overall Study
STARTED
|
35
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Donor Lymphocyte Infusion in Treating Patients With Persistent, Relapsed, or Progressing Cancer After Donor Hematopoietic Cell Transplant
Baseline characteristics by cohort
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=99 Participants
|
|
Age, Continuous
|
59.2 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=99 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 100 days after DLIPercentage of Participants with Grade IV Acute GVHD
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Safety of DLI Following a Non-myeloablative Transplant, Defined as Incidence of Grade IV Acute GVHD
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: 100 days after DLIPercentage patients with graft rejection.
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Incidence of Graft Rejection
|
5.7 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year after DLICML New cytogenetic abnormality and/or development of accelerated phase or blast crisis. The criteria for accelerated phase will be defined as unexplained fever \>38.3°C, new clonal cytogenetic abnormalities in addition to a single Ph-positive chromosome, marrow blasts and promyelocytes \>20%. CMML, AML, ALL \>30% BM blasts w/ deteriorating performance status, or worsening of anemia, neutropenia, or thrombocytopenia. CLL ≥1 of: Physical exam/imaging studies ≥50% increase or new, circulating lymphocytes by morphology and/or flow cytometry ≥50% increase, and lymph node biopsy w/ Richter's transformation. NHL \>25% increase in the sum of the products of the perpendicular diameters of marker lesions, or the appearance of new lesions. MM ≥100% increase of the serum myeloma protein from its lowest level, or reappearance of myeloma peaks that had disappeared w/ treatment; or definite increase in the size or number of plasmacytomas or lytic bone lesions.
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Incidence of Relapse/Progression
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: 100 days after DLIPercentage of Participants with II-IV Acute GVHD
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Incidence of Grade II-IV GVHD in Patients Undergoing DLI Following a Non-myeloablative Transplant
|
14.3 percentage of participants
|
SECONDARY outcome
Timeframe: 100 days after DLIPercentage of Participants with infections.
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Incidence of Infections in Patients Undergoing DLI Following a Non-myeloablative Transplant
|
88.6 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year after DLIPercentage patients surviving 1 year post-transplant.
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Overall Survival
|
71.4 percentage of participants
|
SECONDARY outcome
Timeframe: 1 year after DLIPercentage of patients with progression-free survival
Outcome measures
| Measure |
Treatment (DLI)
n=35 Participants
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Progression-free Survival
|
28.6 percentage of participants
|
Adverse Events
Treatment (DLI)
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (DLI)
n=35 participants at risk
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Immune system disorders
GVHD
|
8.6%
3/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Cardiac disorders
Myocardial infaction
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
Other adverse events
| Measure |
Treatment (DLI)
n=35 participants at risk
Patients undergo unirradiated DLI over 15-30 minutes on day 0. Patients then undergo restaging on day 28 and may undergo a second DLI after at least 4 weeks if no significant GVHD develops and disease status worsens or after at least 8 weeks if disease status is unchanged and persistent donor T-cells are documented.
Therapeutic Allogeneic Lymphocytes: Given IV
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Cardiac disorders
Atrial fibrillation
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Investigations
Blood bilirubin increased
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Hepatobiliary disorders
Cholecystitis
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Immune system disorders
GVHD
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Vascular disorders
Hypotension
|
5.7%
2/35 • Number of events 2 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
5.7%
2/35 • Number of events 3 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Investigations
Neutrophil count decreased
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Renal and urinary disorders
Respiratory, thoracic, and mediastrinal disorders - Other (Unknown)
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Blood and lymphatic system disorders
Spleen disorder
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Vascular disorders
Thromboembolic event
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other (Elevated tacrolimus level)
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Gastrointestinal disorders
Ileal obstruction
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Treatment related secondary malignancy
|
2.9%
1/35 • Number of events 1 • AEs: Conditioning through Day 100; SAEs: Conditioning through Day 200
|
Additional Information
Dr. Brenda M. Sandmaier
Fred Hutchinson Cancer Research Center
Phone: (206) 667-4961
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place