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Transplantation for Patients With Chronic Lymphocytic 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: NCT00186303
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : December 17, 2012
Sponsor:
Information provided by (Responsible Party):
Robert Negrin, Stanford University

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

Condition or disease Intervention/treatment Phase
Leukemia, Lymphocytic, Chronic Procedure: high dose chemotherapy then autologous hematopoietic cell transplant Procedure: ablative allogeneic hematopoietic cell transplant Not Applicable

Detailed Description:
To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
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
Study Start Date : November 1996
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Efficacy

Secondary Outcome Measures :
  1. Feasibility
  2. Toxicity
  3. olymerase Chain Reaction (PCR) for minimal residual disease

Eligibility Criteria
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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
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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
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Robert S Negrin Stanford University
More Information
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Responsible Party: Robert Negrin, Professor, Stanford University
ClinicalTrials.gov Identifier: NCT00186303    
Other Study ID Numbers: BMT88
77066
BMT88
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: December 17, 2012
Last Verified: December 2012
Additional relevant MeSH terms:
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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