Trial Outcomes & Findings for Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NCT NCT00073918)
NCT ID: NCT00073918
Last Updated: 2017-08-18
Results Overview
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
111 participants
Primary outcome timeframe
At year 3
Results posted on
2017-08-18
Participant Flow
Participant milestones
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Overall Study
STARTED
|
111
|
|
Overall Study
COMPLETED
|
107
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Overall Study
Eligibility requirement not met - HAMA+
|
1
|
|
Overall Study
Rapid disease progression
|
2
|
|
Overall Study
Eligibility requirement not met-low CD20
|
1
|
Baseline Characteristics
Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=111 Participants
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
111 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
52.3 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
76 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
101 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
111 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At year 3Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
Outcome measures
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=107 Participants
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Progression-free Survival
|
56 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 15 yearsSurvival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.
Outcome measures
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=107 Participants
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
5 Year Overall Survival
|
72 percentage of participants
|
SECONDARY outcome
Timeframe: From date of transplant through date of relapse/progression or death, assessed up to 15 yearsPopulation: Percentage of patients
Response rates will be estimated as the percentage of patients
Outcome measures
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=111 Participants
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Response Rate
|
41.4 percentage of participants
|
SECONDARY outcome
Timeframe: From date of first exposure to study drug, through date of relapse/progression or other significant medical event confounding further assessment, assessed up to 15 yearsPopulation: Number of Grade 3-4 toxicities.
Grade 3-4 Bearman non-hematologic toxicity will be carefully monitored throughout this study. The protocol will be terminated due to safety concerns if there exists sufficient evidence suggesting that the true rate of grade 3-4 nonhematologic toxicity exceeds 25%. All patients, regardless of histology, will be evaluated together for purposes of toxicity. Sufficient evidence will be taken to be a lower limit to the appropriate 90% one-sided confidence interval in excess of 25%
Outcome measures
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=111 Participants
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
|
9 events
|
Adverse Events
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
n=107 participants at risk
RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.
CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.
AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.
cyclophosphamide: Given IV
etoposide: Given IV
iodine I 131 tositumomab: Given IV
quality-of-life assessment: Ancillary study
peripheral blood stem cell transplantation: Undergo ASCT given via central catheter
|
|---|---|
|
Gastrointestinal disorders
Mucositis/stomatitis
|
1.9%
2/107 • Number of events 2
|
|
Renal and urinary disorders
Renal Failure
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pneumonia syndrome
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
0.93%
1/107 • Number of events 1
|
|
Cardiac disorders
cardiac left ventricular function
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
ARDS
|
0.93%
1/107 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
radiation pneumonitis
|
0.93%
1/107 • Number of events 1
|
Other adverse events
Adverse event data not reported
Additional Information
Ajay K. Gopal, MD
Fred Hutchinson Cancer Research Center
Phone: 206-288-2037
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place