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← Riabni: refractory Non-Hodgkin's Lymphoma

NCT00073918 · 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 refractory 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

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

Kaplan-Meier estimate of progression-free survival at 3 years will be used as the primary determinant of potential efficacy.

Source null

→

secondary · POSTED

Survival will be estimated using the method of Kaplan and Meier. Associated confidence intervals will be provided as part of the analysis.

Source null

→

secondary · POSTED

Response rates will be estimated as the percentage of patients

Percentage of patients

→

secondary · POSTED

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%

Number of Grade 3-4 toxicities.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

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-non-hodgkin-lymphoma-riabni-7424044e
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 refractory 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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-hodgkin-lymphoma-riabni-7424044e
    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