TriangleNCT00073918 · STUDY IN CONTEXT
Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.
Response rates will be estimated as the percentage of patients
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%
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- trial label
- Iodine I 131 Tositumomab, Etoposide and Cyclophosphamide Followed by Autologous Stem Cell Transplant in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 4
- harms Count
- 1
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0000
- source section id
- NCT00073918-om-0000
- source outcome index
- 0
- endpoint
- Progression-free Survival
- endpoint definition
- Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.
- time origin
- At year 3
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0001
- source section id
- NCT00073918-om-0001
- source outcome index
- 1
- endpoint
- 5 Year Overall Survival
- endpoint definition
- Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.
- time origin
- Up to 15 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0002
- source section id
- NCT00073918-om-0002
- source outcome index
- 2
- endpoint
- Response Rate
- endpoint definition
- Response rates will be estimated as the percentage of patients
- time origin
- From date of transplant through date of relapse/progression or death, assessed up to 15 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Percentage of patients
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0003
- source section id
- NCT00073918-om-0003
- source outcome index
- 3
- endpoint
- Toxicity as Assessed by Common Terminology Criteria (CTC) v 2.0
- endpoint definition
- 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%
- time origin
- 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 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Number of Grade 3-4 toxicities.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
- regimen
- 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
- analyzed count
- 107
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00073918-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
- regimen
- 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
- analyzed count
- 107
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00073918-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
- regimen
- 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
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00073918-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
- regimen
- 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
- analyzed count
- 111
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT00073918-om-0003#groups/OG000
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-aggressive-b-cell-non-hodgkin-lymphoma-recurrent-36919cf2
- nct id
- NCT00073918
- harm key
- EG000
- source section id
- NCT00073918-ae
- event group key
- EG000
- event group label
- Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)
- serious affected
- 9
- serious at risk
- 107
- other affected
- 0
- other at risk
- 107
- frequency threshold
- 5
- collection period
- Source null
- event definition
- Source null
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice