Trial Outcomes & Findings for CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies (NCT NCT01664910)
NCT ID: NCT01664910
Last Updated: 2024-07-23
Results Overview
Number of participants received inotuzumab in each cohort without DLT
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2024-07-23
Participant Flow
All recruitment done at the University of Texas MD Anderson Cancer Center.
Participant milestones
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
2
|
21
|
|
Overall Study
COMPLETED
|
4
|
2
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
1
|
Baseline Characteristics
CMC-544 and Allogeneic Transplantation for CD22 Positive-Lymphoid Malignancies
Baseline characteristics by cohort
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
21 participants
n=5 Participants
|
27 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysNumber of participants received inotuzumab in each cohort without DLT
Outcome measures
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Maximum-tolerated Dose (MTD) of Inotuzumab Without DLT
|
4 Participants
|
2 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsOverall response (CR+PR) with estimated with a 95% confidence interval in the dose that is declared the MTD. Complete Response is no clinical or radiological evidence of disease. Partial remission is equal to or more than 50% reduction in lymphadenopathy, liver and or spleen if abnormal at pre-treatment.
Outcome measures
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Overall Response
Complete Response
|
4 Participants
|
2 Participants
|
19 Participants
|
|
Overall Response
Partial Response
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Overall Response
Not Evaluable
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsParticipants are disease free and alive at 3 years post transplant.
Outcome measures
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 Participants
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Overall Survival (OS)
|
4 Participants
|
2 Participants
|
14 Participants
|
Adverse Events
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
Serious events: 2 serious events
Other events: 16 other events
Deaths: 7 deaths
Serious adverse events
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Infections and infestations
Bacterial
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Blood and lymphatic system disorders
HSCT related microangiopathy (TA-TMA)
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
DAH
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
GI GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Chronic GI GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Hepatobiliary disorders
Liver GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
Other adverse events
| Measure |
Cohort 1:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(0.6 mg/m2)
n=4 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 0.6 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 2:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.2 mg/m2)
n=2 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.2 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
Cohort 3:Allogeneic TP for CD22(+) Lymphoid Malignancy Conditioned w/ Flu/Ben/Rit/CMC544(1.8 mg/m2)
n=21 participants at risk
Patients receive inotuzumab ozogamicin IV over 1 hour on day -13, and fludarabine phosphate IV over 1 hour and bendamustine hydrochloride IV over 30 minutes to 1 hour on days -5 to -3. Patients with CD20-positive disease also receive rituximab IV over 4-6 hours on days -6, 1, and 8 and patients with MUD receive anti-thymocyte globulin IV over 3-4 hours on days -2 to -1. All patients also receive tacrolimus IV over 24 hours continuously or PO daily beginning on days -2 to 180 followed by taper in the absence of GVHD and methotrexate IV over 30 minutes on days 1, 3, and 6 (1, 3, 6, and 11 in patients with MUD). Patients undergo allogeneic BM or PBSC transplant on day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BM transplant
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic PBSC or BM transplant
Anti-Thymocyte Globulin: Given IV
Bendamustine Hydrochloride: Given IV
Fludarabine Phosphate: Given IV
Inotuzumab Ozogamicin: Given IV at 1.8 mg/m2
Methotrexate: Given IV
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSC transplant
Rituximab: Given IV
Tacrolimus: Given IV or PO
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
19.0%
4/21 • Number of events 4 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
100.0%
4/4 • Number of events 4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
76.2%
16/21 • Number of events 16 • Up to 3 years
|
|
General disorders
ATG fevers
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
0.00%
0/21 • Up to 3 years
|
|
General disorders
Fluid overload
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
47.6%
10/21 • Number of events 10 • Up to 3 years
|
|
Infections and infestations
Bacterial Infection
|
50.0%
2/4 • Number of events 2 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
38.1%
8/21 • Number of events 8 • Up to 3 years
|
|
Infections and infestations
Viral Infections
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
52.4%
11/21 • Number of events 11 • Up to 3 years
|
|
Investigations
Elevated bilirubin
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia due to Chronic GvHD
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
0.00%
0/21 • Up to 3 years
|
|
Renal and urinary disorders
BK virus induced hemohrragic cystitis
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Chronic lung GvHD
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Chronic skin GvHD
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
42.9%
9/21 • Number of events 9 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin GvHD
|
75.0%
3/4 • Number of events 3 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
38.1%
8/21 • Number of events 8 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin rash due to ATG
|
25.0%
1/4 • Number of events 1 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
0.00%
0/21 • Up to 3 years
|
|
Blood and lymphatic system disorders
Neutropenic fevers
|
0.00%
0/4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Eye disorders
Chronic ocular GvHD
|
0.00%
0/4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
0.00%
0/21 • Up to 3 years
|
|
Gastrointestinal disorders
Chronic oral GvHD
|
0.00%
0/4 • Up to 3 years
|
100.0%
2/2 • Number of events 2 • Up to 3 years
|
47.6%
10/21 • Number of events 10 • Up to 3 years
|
|
Gastrointestinal disorders
GI GvHD
|
0.00%
0/4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
General disorders
Fevers
|
0.00%
0/4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
33.3%
7/21 • Number of events 7 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Skin rash
|
0.00%
0/4 • Up to 3 years
|
50.0%
1/2 • Number of events 1 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Ascitis
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Gastrointestinal disorders
Chronic GI GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
General disorders
Chronic GvHD_Fascitis
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
23.8%
5/21 • Number of events 5 • Up to 3 years
|
|
Hepatobiliary disorders
Chronic liver GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
23.8%
5/21 • Number of events 5 • Up to 3 years
|
|
Reproductive system and breast disorders
Chronic vaginal GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
Investigations
Creatinine increased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Investigations
Ejection fraction decreased
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
General disorders
Elevated transminitis
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
General disorders
Flu like syndrome
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Infections and infestations
Fungal Infections
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
9.5%
2/21 • Number of events 2 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
Eye disorders
Ocular GvHD
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
23.8%
5/21 • Number of events 5 • Up to 3 years
|
|
Nervous system disorders
Orthostatic hypotension
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
14.3%
3/21 • Number of events 3 • Up to 3 years
|
|
General disorders
Venous occlusive disease
|
0.00%
0/4 • Up to 3 years
|
0.00%
0/2 • Up to 3 years
|
4.8%
1/21 • Number of events 1 • Up to 3 years
|
Additional Information
Dr. Issa Khouri, MD/Stem Cell Transplantation and Cellular Therapy Department
The University of Texas 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