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

Tracking Information
First Submitted Date	December 7, 2004
First Posted Date	December 8, 2004
Last Update Posted Date	October 14, 2015
Study Start Date	December 2002
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 22, 2010)	Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually [ Time Frame: Annual throughout survival ]; Toxicity of patients on phase I and II trials by NCI CTC scale annually [ Time Frame: Annual throughout survival ]
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00098566 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	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
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
Brief Summary	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.
Detailed Description	OBJECTIVES: 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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols: FHCRC-296; FHCRC-521; FHCRC-792; FHCRC-915
Condition	Lymphoma; Quality of Life
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: November 9, 2011)	36
Original Enrollment	Not Provided
Actual Study Completion Date	June 2011
Actual Primary Completion Date	June 2011 (Final data collection date for primary outcome measure)
Eligibility Criteria	DISEASE CHARACTERISTICS: Diagnosis of B-cell non-Hodgkin's lymphoma Relapsed or refractory disease; Previously treated with myeloablative doses of iodine I^131 tositumomab and autologous bone marrow or stem cell transplantation on 1 of the following phase I or II protocols: FHCRC-296 FHCRC-521 FHCRC-792 FHCRC-915 PATIENT CHARACTERISTICS: Age; 18 and over Performance status; Not specified Life expectancy; Not specified Hematopoietic; Not specified Hepatic; Not specified Renal; Not specified PRIOR CONCURRENT THERAPY: Biologic therapy; See Disease Characteristics Chemotherapy; Not specified Endocrine therapy; Not specified Radiotherapy; See Disease Characteristics Surgery; Not specified
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 120 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00098566
Other Study ID Numbers	1734.00; FHCRC-1734.00; CDR0000398806 ( Registry Identifier: PDQ )
Has Data Monitoring Committee	Not Provided
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Press, Oliver MD, Fred Hutchinson Cancer Research Center
Study Sponsor	Fred Hutchinson Cancer Research Center
Collaborators	National Cancer Institute (NCI)
Investigators	Principal Investigator: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
PRS Account	Fred Hutchinson Cancer Research Center
Verification Date	October 2015