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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00186381
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 27, 2010
Sponsor:
Information provided by:
Stanford University

Study Description
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Brief Summary:
Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.

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

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Study Start Date : November 1995
Actual Primary Completion Date : March 2007
Actual Study Completion Date : March 2007

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Disease free survival (DFS)

Secondary Outcome Measures :
  1. Transplant related mortality (TRM)
  2. Toxicity
  3. Adequacy of cell collections
  4. Engraftment kinetics

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 69 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00186381


Locations
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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Laura Johnston Stanford University
More Information
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Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186381    
Other Study ID Numbers: BMT8N
77045
BMT8N
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 27, 2010
Last Verified: July 2010
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms