Back to resultsTransplantation for Patients With Chronic Lymphocytic Leukemia
Primary Purpose
Leukemia, Lymphocytic, Chronic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high dose chemotherapy then autologous hematopoietic cell transplant
ablative allogeneic hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Lymphocytic, Chronic
Eligibility Criteria
Inclusion Criteria:- adequate organ function normal bone marrow cytogenetics Exclusion Criteria:- active CNS disease For autologous patients more than 30% bone marrow involvement
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Feasibility
Toxicity
olymerase Chain Reaction (PCR) for minimal residual disease
Full Information
NCT ID
NCT00186303
First Posted
September 13, 2005
Last Updated
December 13, 2012
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00186303
Brief Title
Transplantation for Patients With Chronic Lymphocytic Leukemia
Official Title
Autologous and Allogeneic Peripheral Blood Progenitor (PBPC) Transplantation for Patients With Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
November 1996 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To evaluate the role of high dose therapy and autologous or allogeneic hematopoietic cell transplantation for the treatment of chronic lymphocytic leukemia.
Detailed Description
To determine effectiveness of allogeneic transplantation in eradicating chronic lymphocytic leukemia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphocytic, Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemotherapy then autologous hematopoietic cell transplant
Intervention Type
Procedure
Intervention Name(s)
ablative allogeneic hematopoietic cell transplant
Primary Outcome Measure Information:
Title
Efficacy
Secondary Outcome Measure Information:
Title
Feasibility
Title
Toxicity
Title
olymerase Chain Reaction (PCR) for minimal residual disease
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- adequate organ function
normal bone marrow cytogenetics Exclusion Criteria:- active CNS disease
For autologous patients more than 30% bone marrow involvement
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert S Negrin
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Transplantation for Patients With Chronic Lymphocytic Leukemia
We'll reach out to this number within 24 hrs