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Transplantation for Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert Negrin, Stanford University
ClinicalTrials.gov Identifier:
NCT00186303
First received: September 13, 2005
Last updated: December 13, 2012
Last verified: December 2012
History of Changes
  Purpose

To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.


Condition Intervention
Leukemia, Lymphocytic, Chronic
 Procedure: high dose chemotherapy then autologous hematopoietic cell transplant
Procedure: ablative allogeneic hematopoietic cell transplant

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous and Allogeneic Peripheral Blood Progenitor (PBPC) Transplantation for Patients With Chronic Lymphocytic Leukemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Efficacy [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Feasibility [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • olymerase Chain Reaction (PCR) for minimal residual disease [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 28
Study Start Date: November 1996
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Detailed Description:

To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- adequate organ function - normal bone marrow cytogenetics

Exclusion Criteria:- active CNS disease

- For autologous patients more than 30% bone marrow involvement

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00186303

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Robert S Negrin Stanford University
  More Information

No publications provided

Responsible Party: Robert Negrin, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186303     History of Changes
Other Study ID Numbers: BMT88, 77066, BMT88
Study First Received: September 13, 2005
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
 Leukemia, B-Cell
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 21, 2013