Trial Outcomes & Findings for Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation (NCT NCT03856216)
NCT ID: NCT03856216
Last Updated: 2026-04-15
Results Overview
VOD (veno-occlusive disease) is a severe liver injury caused by chemotherapy drugs and it is usually presents with abdominal pain and swelling, with evidence of portal hypertension and variable degrees of serum enzyme elevations and jaundice.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Up to 45 days post transplant
Results posted on
2026-04-15
Participant Flow
All participants were registered at MD Anderson Cancer Center.
Participant milestones
| Measure |
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 2: FM (Fludarabine/Melphalan)
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
11
|
|
Overall Study
COMPLETED
|
4
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Inotuzumab Ozogamicin and Chemotherapy in Treating Patients With Leukemia or Lymphoma Undergoing Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 2: FM (Fludarabine/Melphalan)
n=11 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=193 Participants
|
7 Participants
n=193 Participants
|
11 Participants
n=386 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=193 Participants
|
9 Participants
n=193 Participants
|
13 Participants
n=386 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=193 Participants
|
2 Participants
n=193 Participants
|
2 Participants
n=386 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=193 Participants
|
6 Participants
n=193 Participants
|
6 Participants
n=386 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=193 Participants
|
5 Participants
n=193 Participants
|
9 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=193 Participants
|
4 Participants
n=193 Participants
|
4 Participants
n=386 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=193 Participants
|
0 Participants
n=193 Participants
|
0 Participants
n=386 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=193 Participants
|
11 participants
n=193 Participants
|
15 participants
n=386 Participants
|
PRIMARY outcome
Timeframe: Up to 45 days post transplantVOD (veno-occlusive disease) is a severe liver injury caused by chemotherapy drugs and it is usually presents with abdominal pain and swelling, with evidence of portal hypertension and variable degrees of serum enzyme elevations and jaundice.
Outcome measures
| Measure |
Cohort 2: FM (Fludarabine/Melphalan)
n=11 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
The Number of Participants Who Experienced VOD (Veno-occlusive Disease) Within 45 Days Post Transplant.
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 1 year post transplant.Number of participants die from cause other than relapsed disease.
Outcome measures
| Measure |
Cohort 2: FM (Fludarabine/Melphalan)
n=11 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
Number of Participants Experienced Treatment-related Mortality (TRM) at 1 Year Post Transplant.
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsNumber of participants that are disease free and alive 3 years after study enrollment.
Outcome measures
| Measure |
Cohort 2: FM (Fludarabine/Melphalan)
n=11 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 Participants
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
Progression-free Survival (PFS)
|
6 Participants
|
2 Participants
|
Adverse Events
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Cohort 2: FM (Fludarabine/Melphalan)
Serious events: 5 serious events
Other events: 10 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 participants at risk
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 2: FM (Fludarabine/Melphalan)
n=11 participants at risk
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
Investigations
Wbc decreased
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Bacterial
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/4 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
General disorders
Edema
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Fungal
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
General disorders
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Platelet count decreased
|
0.00%
0/4 • 3 years
|
18.2%
2/11 • Number of events 3 • 3 years
|
Other adverse events
| Measure |
Cohort 1: BFR (Bendamustine/Fludarabine/Rituximab)
n=4 participants at risk
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Melphalan: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
Cohort 2: FM (Fludarabine/Melphalan)
n=11 participants at risk
Recipients of haploidentical or mismatched unrelated stem cell transplant: Patients will receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day -13, fludarabine IV over 1 hour on days -5 to -2, melphalan IV over 30 minutes on day -3 to -2, total body irradiation on day -1, and tacrolimus IV continuously beginning on day -2 then orally (PO) once daily (QD) or twice daily (BID) for about 6 months. Patients also receive bone marrow or peripheral blood progenitor cells IV on day 0. Patients receive cylophosphamide IV over 3 hours and mesna IV on days +3 to +4 and filgrastim-sndz subcutaneously (SC) QD beginning 1 week after the transplant until blood cell levels return to normal.
Allogeneic Bone Marrow Transplantation: Given IV
Bendamustine: Given IV
Filgrastim-sndz: Given IV
Fludarabine: Given IV
Inotuzumab Ozogamicin: Given IV
Peripheral Blood Stem Cell Transplantation: Given IV
Rituximab: Given IV
Tacrolimus: Given IV and PO
|
|---|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DAH
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/4 • 3 years
|
63.6%
7/11 • Number of events 7 • 3 years
|
|
Renal and urinary disorders
Hemorhagic Cystitis
|
0.00%
0/4 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 2 • 3 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/4 • 3 years
|
18.2%
2/11 • Number of events 3 • 3 years
|
|
Eye disorders
Ocular GVHD
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Oral GVHD
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Oral mucositis
|
0.00%
0/4 • 3 years
|
54.5%
6/11 • Number of events 7 • 3 years
|
|
General disorders
|
0.00%
0/4 • 3 years
|
18.2%
2/11 • Number of events 10 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
T bilirubin increased
|
0.00%
0/4 • 3 years
|
27.3%
3/11 • Number of events 3 • 3 years
|
|
Hepatobiliary disorders
VOD
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Weight loss
|
0.00%
0/4 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Infections and infestations
Bacterial
|
25.0%
1/4 • Number of events 1 • 3 years
|
54.5%
6/11 • Number of events 6 • 3 years
|
|
Skin and subcutaneous tissue disorders
Chronic GVHD
|
25.0%
1/4 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Investigations
Creatinine increased
|
25.0%
1/4 • Number of events 1 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
50.0%
2/4 • Number of events 2 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
1/4 • Number of events 1 • 3 years
|
90.9%
10/11 • Number of events 12 • 3 years
|
|
Eye disorders
Dry eye
|
25.0%
1/4 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
General disorders
Fatigue
|
25.0%
1/4 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 1 • 3 years
|
|
General disorders
Fever
|
25.0%
1/4 • Number of events 1 • 3 years
|
18.2%
2/11 • Number of events 3 • 3 years
|
|
General disorders
Fluid overload
|
50.0%
2/4 • Number of events 2 • 3 years
|
45.5%
5/11 • Number of events 5 • 3 years
|
|
Infections and infestations
Funga
|
25.0%
1/4 • Number of events 1 • 3 years
|
0.00%
0/11 • 3 years
|
|
Nervous system disorders
Headache
|
25.0%
1/4 • Number of events 1 • 3 years
|
72.7%
8/11 • Number of events 9 • 3 years
|
|
Vascular disorders
Hypertension
|
25.0%
1/4 • Number of events 1 • 3 years
|
18.2%
2/11 • Number of events 2 • 3 years
|
|
Blood and lymphatic system disorders
Low granulocyte
|
50.0%
2/4 • Number of events 2 • 3 years
|
90.9%
10/11 • Number of events 12 • 3 years
|
|
Investigations
Low platelet
|
50.0%
2/4 • Number of events 2 • 3 years
|
9.1%
1/11 • Number of events 5 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
3/4 • Number of events 3 • 3 years
|
90.9%
10/11 • Number of events 13 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
2/4 • Number of events 3 • 3 years
|
54.5%
6/11 • Number of events 6 • 3 years
|
|
Infections and infestations
Viral
|
25.0%
1/4 • Number of events 1 • 3 years
|
27.3%
3/11 • Number of events 5 • 3 years
|
|
Investigations
Wbc decreased
|
25.0%
1/4 • Number of events 1 • 3 years
|
9.1%
1/11 • Number of events 3 • 3 years
|
|
Investigations
ALK increased
|
0.00%
0/4 • 3 years
|
36.4%
4/11 • Number of events 4 • 3 years
|
|
Investigations
ALT increased
|
75.0%
3/4 • Number of events 3 • 3 years
|
63.6%
7/11 • Number of events 8 • 3 years
|
|
Investigations
Anemia
|
50.0%
2/4 • Number of events 2 • 3 years
|
9.1%
1/11 • Number of events 5 • 3 years
|
|
Investigations
AST increased
|
75.0%
3/4 • Number of events 3 • 3 years
|
45.5%
5/11 • Number of events 6 • 3 years
|
Additional Information
Issa F. Khouri, MD/Stem cell transplantation department
UT MD Anderson Cancer Center
Phone: 713-745-0049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place