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Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia

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

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003874
Enrollment
Unknown
Registered
2004-07-16
Start date
1999-02-28
Completion date
2001-09-30
Last updated
2011-11-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leukemia, Lymphoma

Keywords

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

Brief 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.

Detailed 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.

Interventions

BIOLOGICALmonoclonal antibody CD19
BIOLOGICALmonoclonal antibody CD20
PROCEDUREin vitro-treated peripheral blood stem cell transplantation

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Fred Hutchinson Cancer Center
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
No minimum to 70 Years
Healthy volunteers
No

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026