Transplantation for Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Information provided by (Responsible Party):
Robert Negrin, Stanford University Identifier:
First received: September 13, 2005
Last updated: December 13, 2012
Last verified: December 2012
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:

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.

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

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
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Please refer to this study by its identifier: NCT00186303

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

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

Additional relevant MeSH terms:
Leukemia, Lymphocytic, Chronic, B-Cell
Leukemia, Lymphoid
Immune System Diseases
Immunoproliferative Disorders
Leukemia, B-Cell
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type processed this record on May 26, 2016