Transplantation for Patients With Chronic Lymphocytic Leukemia

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186303
• Collaborator: (none)
• Enrollment: 28
• Location: 1
• Duration (Months): 159.9
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia, Lymphocytic, Chronic	Procedure: high dose chemotherapy then autologous hematopoietic cell transplant; Procedure: ablative allogeneic hematopoietic cell transplant	N/A

Detailed Description

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

Study Design

• Study Type: Interventional
• Anticipated 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: Nov 1, 1996
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Mar 1, 2010

Outcome Measures

Primary Outcome Measures

1. Efficacy []

Secondary Outcome Measures

1. Feasibility []

2. Toxicity []

3. olymerase Chain Reaction (PCR) for minimal residual disease []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Robert S Negrin, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Robert Negrin, Professor, Stanford University
• ClinicalTrials.gov Identifier: NCT00186303
• Other Study ID Numbers: BMT88; 77066; BMT88
• First Posted: Sep 16, 2005
• Last Update Posted: Dec 17, 2012
• Last Verified: Dec 1, 2012

• Additional relevant MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell

Study Results

No Results Posted as of Dec 17, 2012