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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00098566
First received: December 7, 2004
Last updated: April 10, 2012
Last verified: April 2012
  Purpose

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.


Condition Phase
Lymphoma
Quality of Life
Phase 2

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: December 2002
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00098566

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Oliver W. Press, MD, PhD Fred Hutchinson Cancer Research Center
  More Information

Additional Information:
No publications provided

Responsible Party: Press, Oliver MD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00098566     History of Changes
Other Study ID Numbers: 1734.00, FHCRC-1734.00, CDR0000398806
Study First Received: December 7, 2004
Last Updated: April 10, 2012
Health Authority: United States: Federal Government

Keywords provided by Fred Hutchinson Cancer Research Center:
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

Additional relevant MeSH terms:
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 22, 2014