Long-Term Effects of Iodine I Tositumomab and Autologous Bone Marrow or Stem Cell Transplantation in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
RATIONALE: Studying the long-term effects of cancer treatment in cancer survivors may help improve the ability to plan effective treatment and follow-up care.
PURPOSE: This phase II trial is studying the long-term effects of iodine I 131 tositumomab and autologous bone marrow or stem cell transplantation in patients with relapsed or refractory non-Hodgkin's lymphoma.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Long-Term Follow-Up Study Evaluating the Efficacy and Delayed Toxicities of Radioiodinated Tositumomab (Anti-CD20 Antibody) Followed by Autologous Transplantation for Relapsed or Refractory Non-Hodgkin's Lymphoma|
- Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually [ Time Frame: Annual throughout survival ] [ Designated as safety issue: No ]
- Toxicity of patients on phase I and II trials by NCI CTC scale annually [ Time Frame: Annual throughout survival ] [ Designated as safety issue: Yes ]
|Study Start Date:||December 2002|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
- Determine the progression-free survival and overall survival of patients with relapsed or refractory B-cell non-Hodgkin's lymphoma previously treated with iodine I^131 tositumomab followed by autologous bone marrow or stem cell transplantation on FHCRC protocols 296, 521, 792, or 915.
- Determine the long-term toxic effects of this regimen in these patients.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is a long-term, follow-up study.
Patients undergo testing for human anti-mouse antibody at 1, 3 and 12 months. Patients undergo physical examinations, blood tests, and immune system assessments every 3 months for 1 year and then annually thereafter. Thyroid, pulmonary, and cardiac function are assessed at 1 year and then annually as needed. Patients also undergo CT scans and bone marrow biopsy (if clinically indicated) annually for up to 10 years.
Quality of life is assessed annually.
PROJECTED ACCRUAL: A total of 47 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00098566
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109-1024|
|Principal Investigator:||Oliver W. Press, MD, PhD||Fred Hutchinson Cancer Research Center|