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NCT00003874 Clinical Trial

Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia

Lymphoma Clinical Trial

Official title:
A Phase I/II Study of Combined Enrichment of CD34+ Cells and Depletion of B-Cells From Peripheral Blood Stem Cell Components for Patients With B-Lymphoid Malignancies

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00003874
Other study ID # 1345.00
Secondary ID FHCRC-1345.00NCI
Status Completed
Phase Phase 1/Phase 2
First received November 1, 1999
Last updated November 28, 2011
Start date February 1999
Est. completion date September 2001

Study information
Verified date November 2011
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances without harming normal cells.

PURPOSE: Phase I/II trial to study the effectiveness of monoclonal antibody therapy in treating patients who have lymphoma or leukemia.

Description:

OBJECTIVES: I. Evaluate the efficiency of tumor cell removal by immunomagnetic technique in patients with B cell malignancies. II. Determine toxicity of mobilized peripheral blood stem cell (PBSC) components of enriched CD34+ and depleted B cells in this patient population. III. Compare recovery with the use of this treatment regimen to the use of unmanipulated PBSC or CD34+ PBSC components in this patient population.

OUTLINE: Patients are assigned to one of two treatment arms for chemotherapy (chemotherapy protocol following FHCRC-506.2). Patients undergo mobilization and isolation of CD34+ cells as described in FHCRC-506.2. Peripheral blood stem cells are collected by apheresis and the CD34+ cells are isolated using magnetic beads. Monoclonal antibodies to CD19 and CD20 are added to the CD34+ cells to sensitize any remaining tumor cells. Patients undergo transplantation on day 0, according to applicable transplant protocols, one month after mobilization. Some patients may receive posttransplant interleukin-2 after achieving durable engraftment. Patients are followed at day 30, 80, 180, 365, and 395.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date September 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 70 Years
Eligibility DISEASE CHARACTERISTICS: Histologically confirmed recurrent B cell malignancy that is positive for CD19 and/or CD20 antigens Demonstrated or probable tumor cell contamination of peripheral blood stem cell components No CNS metastases High risk B cell malignancy indicative of autologous hematopoietic stem cell transplantation No HLA matched donors Eligible for mobilization of blood stem cells using chemotherapy and G-CSF Eligible for transplantation on a protocol covering classification and stage of malignancy Intention to proceed to transplantation within 60 days of peripheral blood stem cell collection

PATIENT CHARACTERISTICS: Age: 70 and under Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No active infection HIV negative Adequate organ function as defined in the mobilization and transplant protocols At least 20 CD34+ cells/uL in the peripheral blood before immunomagnetic separation

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: Not specified

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• monoclonal antibody CD19

• monoclonal antibody CD20

Procedure:
• in vitro-treated peripheral blood stem cell transplantation

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, 

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