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

This study has been completed.
Sponsor:
Information provided by:
Stanford University
ClinicalTrials.gov Identifier:
NCT00186381
First received: September 13, 2005
Last updated: July 23, 2010
Last verified: July 2010
  Purpose

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


Condition Intervention Phase
Leukemia, Myelocytic, Acute
Leukemia
Blood and Marrow Transplant (BMT)
Procedure: high dose chemotherapy then autologous hematopoietic cell transplant
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Disease free survival (DFS) [ Time Frame: unknown ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Transplant related mortality (TRM) [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: unknown ] [ Designated as safety issue: Yes ]
  • Adequacy of cell collections [ Time Frame: unknown ] [ Designated as safety issue: No ]
  • Engraftment kinetics [ Time Frame: unknown ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 1995
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   16 Years to 69 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- must be in remission

- adequate organ function

Exclusion Criteria:- prior MDS

  • active infection
  • liver disease
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00186381

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Laura Johnston Stanford University
  More Information

No publications provided

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186381     History of Changes
Other Study ID Numbers: BMT8N, 77045, BMT8N
Study First Received: September 13, 2005
Last Updated: July 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 20, 2014