Trial Outcomes & Findings for Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer (NCT NCT00054327)
NCT ID: NCT00054327
Last Updated: 2013-07-24
Results Overview
Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
at day 42
Results posted on
2013-07-24
Participant Flow
Thirty-five patients were recruited from local medical clinic from November 2000 through November 2009.One patient relapsed and never received a transplant.
Participant milestones
| Measure |
Regimen A
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
4
|
3
|
4
|
10
|
2
|
|
Overall Study
COMPLETED
|
10
|
4
|
3
|
4
|
10
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Regimen A
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Overall Study
Engraftment failure
|
1
|
0
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
Baseline characteristics by cohort
| Measure |
Regimen A
n=11 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
21 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
18 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
33 Participants
n=8 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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
34 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (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
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: at day 42Number of days that patients take to reach engraftment defined as time to hematologic engraftment will be defined as ANC \>500/µl and platelets \>20K/µl without transfusion support.
Outcome measures
| Measure |
Regimen A
n=10 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Rates of Durable Engraftment
|
17.9 days
Standard Deviation 5.801341
|
15.75 days
Standard Deviation 6.946222
|
13 days
Standard Deviation 3
|
18.25 days
Standard Deviation 4.573474
|
13.9 days
Standard Deviation 5.237684
|
10.5 days
Standard Deviation 0.707107
|
SECONDARY outcome
Timeframe: at 100 days post transplantNumber of patients that develop acute graft-versus-host disease by grades 0-4. Grade O is no development of GVHD. Grade 1-4 is increase severity of skin, liver and gut involvement with 1 being least severe and 4 being most severe.
Outcome measures
| Measure |
Regimen A
n=10 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Graft-versus-host Disease (GVHD)
Grade 0
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Graft-versus-host Disease (GVHD)
Grade 1
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Graft-versus-host Disease (GVHD)
Grade 2
|
6 participants
|
2 participants
|
1 participants
|
0 participants
|
5 participants
|
0 participants
|
|
Graft-versus-host Disease (GVHD)
Grade 3
|
2 participants
|
0 participants
|
0 participants
|
3 participants
|
3 participants
|
0 participants
|
|
Graft-versus-host Disease (GVHD)
Grade 4
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: at day 100 post transplantNumber of patients that have disease recurrence.
Outcome measures
| Measure |
Regimen A
n=10 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Incidence of Recurrent Disease
|
4 participants
|
2 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: at 100 days post transplantNumber of patients that experience grade 3 or above toxicity. See serious adverse event list for toxicities.
Outcome measures
| Measure |
Regimen A
n=11 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Toxicity as Measured by CTC v2.0
|
0 participants
|
0 participants
|
1 participants
|
2 participants
|
2 participants
|
0 participants
|
POST_HOC outcome
Timeframe: at 2 years from transplantOutcome measures
| Measure |
Regimen A
n=11 Participants
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 Participants
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 Participants
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 Participants
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 Participants
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 Participants
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Number of Patients With Overall Survival at 2 Years.
|
5 participants
|
2 participants
|
2 participants
|
1 participants
|
5 participants
|
1 participants
|
Adverse Events
Regimen A
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen B-1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen B-2
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen B-3
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen C
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Regimen D
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Regimen A
n=11 participants at risk
Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
|
Regimen B-1
n=4 participants at risk
Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
|
Regimen B-2
n=3 participants at risk
Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
|
Regimen B-3
n=4 participants at risk
Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
|
Regimen C
n=10 participants at risk
Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
|
Regimen D
n=2 participants at risk
Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Melena/GI bleeding
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
33.3%
1/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Investigations
Elevated Bilirubin associated with graft versus host disease (GVHD)
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
33.3%
1/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Nervous system disorders
Memory loss
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
33.3%
1/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
General disorders
Edema
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
33.3%
1/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis (oral/pharyngeal mucositis)
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Psychiatric disorders
Mood alteration-anxiety, agitation
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Skin and subcutaneous tissue disorders
Rash/dermatitis associated with high-dose chemotherapy or BMT studies.
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Gastrointestinal disorders
Petechiae/purpura (hemorrhage/bleeding into skin or mucosa)
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
General disorders
Death not associated with CTCAE term - Multi-organ failure
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
10.0%
1/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Psychiatric disorders
Confusion
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
25.0%
1/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
10.0%
1/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/3 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/4 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
10.0%
1/10 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
0.00%
0/2 • Adverse events were collected while patients were on study over a an eleven year period. Only grade 3 and above toxicity were collected.
"0" Total Number of Participants at Risk (e.g.., other \[non-serious\] adverse events were not collected or assessed as part of the study).
|
Other adverse events
Adverse event data not reported
Additional Information
Kenneth Cooke MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-3345
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place