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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

Phase 1/Phase 2
70 Years
Not Enrolling
Leukemia, Lymphoma

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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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Scott D. Rowley, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

Hackensack University Medical Center Cancer Center


United States: Federal Government

Study ID:




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



Fred Hutchinson Cancer Research Center Seattle, Washington  98109