Transplantation for Patients With Chronic Lymphocytic Leukemia

Leukemia, Lymphocytic, Chronic Clinical Trial

Official title:

Autologous and Allogeneic Peripheral Blood Progenitor (PBPC) Transplantation for Patients With Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00186303
• Other study ID #: BMT88
• Secondary ID: 77066BMT88
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: December 13, 2012
• Start date: November 1996
• Est. completion date: March 2010

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:- adequate organ function - normal bone marrow cytogenetics

Exclusion Criteria:- active CNS disease

• For autologous patients more than 30% bone marrow involvement

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphocytic, Chronic
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid

Intervention

Procedure:
• high dose chemotherapy then autologous hematopoietic cell transplant

• ablative allogeneic hematopoietic cell transplant

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy		unknown	No
Secondary	Feasibility		unknown	No
Secondary	Toxicity		unknown	Yes
Secondary	olymerase Chain Reaction (PCR) for minimal residual disease		unknown	No