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
18 Years
N/A
Both
Lymphoma, Quality of Life
Trial Information
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
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.
Inclusion 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually
Outcome Time Frame:
Annual throughout survival
Safety Issue:
No
Principal Investigator
Oliver W. Press, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Federal Government
Study ID:
1734.00
NCT ID:
NCT00098566
Start Date:
December 2002
Completion Date:
June 2011
Related Keywords:
- Lymphoma
- Quality of Life
- quality of life
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent small lymphocytic lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- Waldenstrom macroglobulinemia
- recurrent adult grade III lymphomatoid granulomatosis
- splenic marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
