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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Quality of Life

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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 CenterSeattle, Washington  98109