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

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00098566
• Other study ID #: 1734.00
• Secondary ID: FHCRC-1734.00CDR
• Status: Completed
• Phase: Phase 2
• First received: December 7, 2004
• Last updated: October 13, 2015
• Start date: December 2002
• Est. completion date: June 2011

Study information

• Verified date: October 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Quality of Life

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free and overall survival of patients on phase I and II trials by Kaplan Meier survival analyses annually		Annual throughout survival	No
Primary	Toxicity of patients on phase I and II trials by NCI CTC scale annually		Annual throughout survival	Yes