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NCT00186381 Clinical Trial

Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Leukemia Clinical Trial

Official title:
Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00186381
Other study ID # BMT8N
Secondary ID 77045BMT8N
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated July 23, 2010
Start date November 1995
Est. completion date March 2007

Study information
Verified date July 2010
Source Stanford University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

Description:

To use high dose chemotherapy with autologous stem cell rescue to try to increase the chance of long term control and cure of the disease.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date March 2007
Est. primary completion date March 2007
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 69 Years
Eligibility Inclusion Criteria:- must be in remission

- adequate organ function

Exclusion Criteria:- prior MDS

- active infection

- liver disease

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• high dose chemotherapy then autologous 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 Disease free survival (DFS) unknown No
Secondary Transplant related mortality (TRM) unknown Yes
Secondary Toxicity unknown Yes
Secondary Adequacy of cell collections unknown No
Secondary Engraftment kinetics unknown No
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