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Transplantation for Patients With Chronic Lymphocytic Leukemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186303
First Posted: September 16, 2005
Last Update Posted: December 17, 2012
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.
Information provided by (Responsible Party):
Robert Negrin, Stanford University
  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
Intervention Model: Parallel Assignment
Masking: None (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 Robert Negrin, Stanford University:

Primary Outcome Measures:
  • Efficacy

Secondary Outcome Measures:
  • Feasibility
  • Toxicity
  • olymerase Chain Reaction (PCR) for minimal residual disease

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Robert Negrin, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186303     History of Changes
Other Study ID Numbers: BMT88
77066
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: December 17, 2012
Last Verified: December 2012

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