Trial Outcomes & Findings for Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma (NCT NCT01701986)
NCT ID: NCT01701986
Last Updated: 2025-02-28
Results Overview
Dose limiting toxicity is defined as number of participants experienced grade 3-4 mucositis lasting for more than 3 days at peak severity, grade 3-4 skin toxicity lasting for more than 3 days at peak severity, occurring within 30 days from transplant, or grade 4 nonhematological/noninfectious toxicity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
64 participants
Primary outcome timeframe
Within 30 days of transplant
Results posted on
2025-02-28
Participant Flow
All participants were registered in MD Anderson Cancer Center
Participant milestones
| Measure |
Cohort 1_475mgm2
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Overall Study
STARTED
|
8
|
24
|
32
|
|
Overall Study
COMPLETED
|
8
|
24
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gemcitabine Hydrochloride, Clofarabine, and Busulfan Before Donor Stem Cell Transplant in Treating Patients With Refractory B-Cell or T-Cell Non-Hodgkin Lymphoma or Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Cohort 1_475mgm2
n=8 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
63 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
49 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
|
8 participants
n=5 Participants
|
24 participants
n=7 Participants
|
32 participants
n=5 Participants
|
64 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Within 30 days of transplantDose limiting toxicity is defined as number of participants experienced grade 3-4 mucositis lasting for more than 3 days at peak severity, grade 3-4 skin toxicity lasting for more than 3 days at peak severity, occurring within 30 days from transplant, or grade 4 nonhematological/noninfectious toxicity.
Outcome measures
| Measure |
Cohort 1_475mgm2
n=8 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity
Mucositis
|
0 Participants
|
6 Participants
|
20 Participants
|
|
Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity
Skin
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Optimal Dose of Gemcitabine Hydrochloride Determined by Dose Limiting Toxicity
Nonhematological/noninfectious toxicity
|
3 Participants
|
6 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 100 days post transplantNumber of participants that are alive, engrafted, without grade 3-4 GVHD within 100 days post transplant.
Outcome measures
| Measure |
Cohort 1_475mgm2
n=8 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Number of Participants That Had 100 Day Success Rate Post Transplant
|
6 Participants
|
17 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: Up to 5 yearsNumber of participants that are still alive 5 years post transplant.
Outcome measures
| Measure |
Cohort 1_475mgm2
n=8 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Overall Survival
|
2 Participants
|
8 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 100 days post-transplantNumber of participants that expired from transplant other than disease relapse within the first 100 days post transplant.
Outcome measures
| Measure |
Cohort 1_475mgm2
n=8 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 Participants
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Treatment Related Mortality
|
2 Participants
|
1 Participants
|
3 Participants
|
Adverse Events
Cohort 1_475mgm2
Serious events: 2 serious events
Other events: 8 other events
Deaths: 6 deaths
Cohort 2_675mgm2
Serious events: 2 serious events
Other events: 24 other events
Deaths: 16 deaths
Cohort 3_975mgm2
Serious events: 9 serious events
Other events: 32 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Cohort 1_475mgm2
n=8 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Investigations
ALT increased
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Investigations
AST increased
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
9.4%
3/32 • Number of events 3 • 5 years
|
|
Infections and infestations
Bacterial
|
12.5%
1/8 • Number of events 1 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
28.1%
9/32 • Number of events 9 • 5 years
|
|
Blood and lymphatic system disorders
BL OTH
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Broncholitis obliterans
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
0.00%
0/32 • 5 years
|
|
Investigations
Creatinine increased
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
21.9%
7/32 • Number of events 7 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Infections and infestations
Fungal
|
25.0%
2/8 • Number of events 2 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
GI OTH
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Low granulocyte
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Investigations
Low platelet
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
12.5%
4/32 • Number of events 4 • 5 years
|
|
General disorders
Other
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Blood and lymphatic system disorders
Primary graft failure
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • Number of events 2 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Secondary graft failure
|
12.5%
1/8 • Number of events 1 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
General disorders
Sepsis like syndrome
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Infections and infestations
Viral
|
25.0%
2/8 • Number of events 2 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
12.5%
4/32 • Number of events 4 • 5 years
|
Other adverse events
| Measure |
Cohort 1_475mgm2
n=8 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 2_675mgm2
n=24 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
Cohort 3_975mgm2
n=32 participants at risk
PREPARATIVE REGIMEN: Patients receive gemcitabine hydrochloride IV over 40-180 minutes on days -6 and -4, clofarabine IV over 1 hour on days -6 to -3, and busulfan IV over 3 hours on days -6 to -3. Patients with matched unrelated donors also receive antithymocyte globulin IV on days -3 to -1 and patients with CD20-positive disease also receive rituximab IV on days -14, -7, 1, and 8.
TRANSPLANT: Patients undergo allogeneic BMT or PBSCT on day 0.
GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously over 24 hours or PO beginning on day -2 for up to 6 months and mycophenolate mofetil IV over 2 hours or PO TID beginning day 0.
Allogeneic Bone Marrow Transplantation: Undergo allogeneic BMT
Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic BMT or PBSCT
Anti-Thymocyte Globulin: Given IV
Busulfan: Given IV
Clofarabine: Given IV
Gemcitabine Hydrochloride: Given IV
Mycophenolate Mofetil: Given IV then PO
Peripheral Blood Stem Cell Transplantation: Undergo allogeneic PBSCT
Pharmacological Study: Correlative studies
Rituximab: Given IV
Tacrolimus: Given IV then PO
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Investigations
ALK increased
|
12.5%
1/8 • Number of events 1 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
34.4%
11/32 • Number of events 11 • 5 years
|
|
Investigations
ALT increased
|
87.5%
7/8 • Number of events 7 • 5 years
|
66.7%
16/24 • Number of events 16 • 5 years
|
100.0%
32/32 • Number of events 34 • 5 years
|
|
Investigations
Anemia
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Ascitis
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Investigations
AST increased
|
0.00%
0/8 • 5 years
|
16.7%
4/24 • Number of events 4 • 5 years
|
53.1%
17/32 • Number of events 17 • 5 years
|
|
Infections and infestations
Bacterial
|
87.5%
7/8 • Number of events 7 • 5 years
|
100.0%
24/24 • Number of events 31 • 5 years
|
100.0%
32/32 • Number of events 46 • 5 years
|
|
Blood and lymphatic system disorders
Bleeding (no GI no PUL)
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Broncholitis obliterans
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Cardiac disorders
Chest pain
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Skin and subcutaneous tissue disorders
Chronic GVHD
|
0.00%
0/8 • 5 years
|
12.5%
3/24 • Number of events 3 • 5 years
|
0.00%
0/32 • 5 years
|
|
Psychiatric disorders
Confusion
|
12.5%
1/8 • Number of events 1 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
9.4%
3/32 • Number of events 3 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Investigations
Creatinine increased
|
12.5%
1/8 • Number of events 1 • 5 years
|
20.8%
5/24 • Number of events 5 • 5 years
|
37.5%
12/32 • Number of events 12 • 5 years
|
|
Renal and urinary disorders
Cystitis noninfective
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
4/8 • Number of events 4 • 5 years
|
62.5%
15/24 • Number of events 15 • 5 years
|
87.5%
28/32 • Number of events 28 • 5 years
|
|
Eye disorders
Dry eye
|
37.5%
3/8 • Number of events 3 • 5 years
|
12.5%
3/24 • Number of events 3 • 5 years
|
0.00%
0/32 • 5 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Cardiac disorders
Dysrhythmia
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
12.5%
4/32 • Number of events 4 • 5 years
|
|
Cardiac disorders
Ejection fraction decreased
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
Nervous system disorders
Encephalopathy
|
12.5%
1/8 • Number of events 1 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
General disorders
Fatigue
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
50.0%
4/8 • Number of events 4 • 5 years
|
66.7%
16/24 • Number of events 16 • 5 years
|
75.0%
24/32 • Number of events 24 • 5 years
|
|
General disorders
Fever
|
37.5%
3/8 • Number of events 3 • 5 years
|
33.3%
8/24 • Number of events 8 • 5 years
|
34.4%
11/32 • Number of events 11 • 5 years
|
|
General disorders
Flu like syndrome
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
0.00%
0/32 • 5 years
|
|
General disorders
Fluid overload
|
62.5%
5/8 • Number of events 5 • 5 years
|
54.2%
13/24 • Number of events 13 • 5 years
|
68.8%
22/32 • Number of events 22 • 5 years
|
|
Infections and infestations
Fungal
|
12.5%
1/8 • Number of events 1 • 5 years
|
25.0%
6/24 • Number of events 6 • 5 years
|
9.4%
3/32 • Number of events 3 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
GI OTH
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
GI ULC
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Investigations
Haptoglobin
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • 5 years
|
12.5%
3/24 • Number of events 3 • 5 years
|
18.8%
6/32 • Number of events 6 • 5 years
|
|
Renal and urinary disorders
Hemorrhagic Cystitis
|
0.00%
0/8 • 5 years
|
20.8%
5/24 • Number of events 5 • 5 years
|
34.4%
11/32 • Number of events 11 • 5 years
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Hepatobiliary disorders
HP OTH
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
0.00%
0/32 • 5 years
|
|
Blood and lymphatic system disorders
HSCT related microangiopathy (TA-TMA)
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • Number of events 1 • 5 years
|
25.0%
6/24 • Number of events 6 • 5 years
|
21.9%
7/32 • Number of events 7 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
9.4%
3/32 • Number of events 3 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Investigations
LDH increased
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Blood and lymphatic system disorders
Low granulocyte
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Investigations
Low platelet
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
Lower Gl track obstruction
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
75.0%
6/8 • Number of events 6 • 5 years
|
100.0%
24/24 • Number of events 31 • 5 years
|
100.0%
32/32 • Number of events 52 • 5 years
|
|
Eye disorders
Ocular GvHD
|
0.00%
0/8 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Gastrointestinal disorders
Oral GvHD
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
6.2%
2/32 • Number of events 2 • 5 years
|
|
Gastrointestinal disorders
Oral mucositis
|
100.0%
8/8 • Number of events 8 • 5 years
|
100.0%
24/24 • Number of events 26 • 5 years
|
100.0%
32/32 • Number of events 34 • 5 years
|
|
General disorders
Other
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
9.4%
3/32 • Number of events 3 • 5 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia
|
12.5%
1/8 • Number of events 1 • 5 years
|
8.3%
2/24 • Number of events 2 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Infections and infestations
Parasite
|
12.5%
1/8 • Number of events 1 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
12.5%
1/8 • Number of events 1 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
25.0%
2/8 • Number of events 2 • 5 years
|
33.3%
8/24 • Number of events 8 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Nervous system disorders
PRES
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
PU OTH
|
0.00%
0/8 • 5 years
|
4.2%
1/24 • Number of events 1 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
8/8 • Number of events 8 • 5 years
|
70.8%
17/24 • Number of events 17 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Blood and lymphatic system disorders
Schistocytes
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Immune system disorders
Serum sickness
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Investigations
T bilirubin increased
|
75.0%
6/8 • Number of events 6 • 5 years
|
62.5%
15/24 • Number of events 15 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • 5 years
|
12.5%
3/24 • Number of events 3 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Nervous system disorders
Tremor
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
15.6%
5/32 • Number of events 5 • 5 years
|
|
Infections and infestations
Viral
|
87.5%
7/8 • Number of events 7 • 5 years
|
100.0%
24/24 • Number of events 34 • 5 years
|
100.0%
32/32 • Number of events 45 • 5 years
|
|
Hepatobiliary disorders
VOD
|
12.5%
1/8 • Number of events 1 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
3.1%
1/32 • Number of events 1 • 5 years
|
|
Investigations
Wbc decreased
|
0.00%
0/8 • 5 years
|
0.00%
0/24 • 5 years
|
0.00%
0/32 • 5 years
|
Additional Information
Dr. Yago Nieto, MD, PhD/ Stem Cell Transplantation Department
University of Texas MD Anderson Cancer Center
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place