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Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00003874
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : November 29, 2011
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Tracking Information
First Submitted Date  ICMJE November 1, 1999
First Posted Date  ICMJE July 16, 2004
Last Update Posted Date November 29, 2011
Study Start Date  ICMJE February 1999
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Monoclonal Antibody Therapy in Treating Patients With Lymphoma or Leukemia
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Primary Purpose: Treatment
Condition  ICMJE
  • Leukemia
  • Lymphoma
Intervention  ICMJE
  • Biological: monoclonal antibody CD19
  • Biological: monoclonal antibody CD20
  • Procedure: in vitro-treated peripheral blood stem cell transplantation
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Study Completion Date  ICMJE September 2001
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00003874
Other Study ID Numbers  ICMJE 1345.00
FHCRC-1345.00
NCI-G99-1514
CDR0000067039 ( Registry Identifier: PDQ )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Fred Hutchinson Cancer Research Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Scott D. Rowley, MD, FACP Hackensack University Medical Center Cancer Center
PRS Account Fred Hutchinson Cancer Research Center
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP