Trial Outcomes & Findings for Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT) (NCT NCT01490723)
NCT ID: NCT01490723
Last Updated: 2020-05-05
Results Overview
Number of participants without treatment related mortality at day 100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
100 days
Results posted on
2020-05-05
Participant Flow
Participant milestones
| Measure |
Yttrium-90 Ibritumomab + Chemo
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Overall Study
STARTED
|
20
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)
Baseline characteristics by cohort
| Measure |
Yttrium-90 Ibritumomab + Chemo
n=20 Participants
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 100 daysNumber of participants without treatment related mortality at day 100.
Outcome measures
| Measure |
Yttrium-90 Ibritumomab + Chemo
n=20 Participants
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Treatment-Related Mortality (TRM)
|
18 Participants
|
SECONDARY outcome
Timeframe: From date of treatment to date of relapse or death, up to 3 yearsPercentage of participants alive at 3 years.
Outcome measures
| Measure |
Yttrium-90 Ibritumomab + Chemo
n=20 Participants
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Overall Survival (OS)
|
14 Participants
|
Adverse Events
Yttrium-90 Ibritumomab + Chemo
Serious events: 12 serious events
Other events: 18 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Yttrium-90 Ibritumomab + Chemo
n=20 participants at risk
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
4/20 • up to 3 years
|
|
Infections and infestations
Sepsis
|
5.0%
1/20 • up to 3 years
|
|
Infections and infestations
Infections and Infestations
|
40.0%
8/20 • up to 3 years
|
|
Vascular disorders
Thromboembolic
|
5.0%
1/20 • up to 3 years
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
40.0%
8/20 • up to 3 years
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
1/20 • up to 3 years
|
|
Cardiac disorders
Left ventricular systolic dysfunction
|
5.0%
1/20 • up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
1/20 • up to 3 years
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • up to 3 years
|
|
Infections and infestations
Upper Respiratory Infection
|
5.0%
1/20 • up to 3 years
|
Other adverse events
| Measure |
Yttrium-90 Ibritumomab + Chemo
n=20 participants at risk
Day -22 and -14, Rituximab 250 mg/m2 preceding In Ibritumomab and ibritumomab tiuxetan administration, respectively. Day -22, -21 to -16, Imaging, repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Day -14,ibritumomab tiuxetan administration. Day -5, -4 and -3, Fludarabine and Bendamustine following Stem Cell Transplant (SCT) and CT. Fludarabine 30 mg/m2 intravenously followed by Bendamustine 130 mg/m2 intravenously. All patients receive Graft Versus Host Disease (GvHD) prophylaxis, infections disease prophylaxis, growth factors, blood and platelet transfusion and other supportive treatment.
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
85.0%
17/20 • up to 3 years
|
|
Vascular disorders
Hypertension
|
20.0%
4/20 • up to 3 years
|
|
Investigations
Creatinine increased
|
10.0%
2/20 • up to 3 years
|
|
Infections and infestations
Fever
|
40.0%
8/20 • up to 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
30.0%
6/20 • up to 3 years
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • up to 3 years
|
|
Infections and infestations
Infection
|
10.0%
2/20 • up to 3 years
|
|
Vascular disorders
Thromboembolic
|
5.0%
1/20 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
20.0%
4/20 • up to 3 years
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
1/20 • up to 3 years
|
|
Investigations
Weight gain
|
20.0%
4/20 • up to 3 years
|
|
Gastrointestinal disorders
Mucositis oral
|
35.0%
7/20 • up to 3 years
|
|
Investigations
Blood bilirubin increased
|
5.0%
1/20 • up to 3 years
|
|
Eye disorders
Eye disorder
|
5.0%
1/20 • up to 3 years
|
Additional Information
Issa F. Khouri, M.D., Stem Cell Transplantation
U.T. MD Anderson Cancer Center
Phone: (713) 745-0049
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place