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Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
This study has been completed.
First Received: November 1, 1999   Last Updated: February 6, 2009   History of Changes
Sponsors and Collaborators: Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00003874
  Purpose

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.


Condition Intervention Phase
Leukemia
Lymphoma
Biological: monoclonal antibody CD19
Biological: monoclonal antibody CD20
Procedure: in vitro-treated peripheral blood stem cell transplantation
Phase I
Phase II

Study Type: Interventional
Study Design: Treatment
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 1999
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.

  Eligibility

Ages Eligible for Study:   up to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003874

Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Study Chair: Scott D. Rowley, MD, FACP Hackensack University Medical Center Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067039, FHCRC-1345.00, NCI-G99-1514
Study First Received: November 1, 1999
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00003874     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Acute Lymphoblastic Leukemia, Childhood
Leukemia, Lymphoid
Immunologic Factors
Lymphoma, Mantle-Cell
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Mantle Cell Lymphoma
Lymphoblastic Lymphoma
Follicular Lymphoma
Lymphoma, Large-cell, Immunoblastic
Antibodies, Monoclonal
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large-Cell, Immunoblastic
Lymphoma, Large-cell
Leukemia, B-cell, Chronic
Lymphoma
Acute Lymphoblastic Leukemia
Immunoglobulins
Lymphoma, Large B-Cell, Diffuse
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Immunoproliferative Disorders
Small Non-cleaved Cell Lymphoma
Recurrence
Burkitt's Lymphoma
Lymphatic Diseases
Antibodies
Waldenstrom Macroglobulinemia

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibodies, Monoclonal
Leukemia
Lymphatic Diseases
Neoplasms
Antibodies
Lymphoproliferative Disorders
Lymphoma
Immunoglobulins

ClinicalTrials.gov processed this record on September 01, 2009