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
N/A
70 Years
Both
Leukemia, Lymphoma
Trial Information
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
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Scott D. Rowley, MD, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
Hackensack University Medical Center Cancer Center
Authority:
United States: Federal Government
Study ID:
1345.00
NCT ID:
NCT00003874
Start Date:
February 1999
Completion Date:
September 2001
Related Keywords:
- Leukemia
- Lymphoma
- recurrent childhood acute lymphoblastic leukemia
- Waldenstrom macroglobulinemia
- recurrent childhood lymphoblastic lymphoma
- recurrent adult acute lymphoblastic leukemia
- refractory chronic lymphocytic leukemia
- B-cell chronic lymphocytic leukemia
- B-cell childhood acute lymphoblastic leukemia
- B-cell adult acute lymphoblastic leukemia
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent childhood small noncleaved cell lymphoma
- recurrent childhood large cell lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- Leukemia
- Lymphoma
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
