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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00186381
First Posted: September 16, 2005
Last Update Posted: July 27, 2010
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.
Information provided by:
Stanford University
  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
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Disease free survival (DFS)

Secondary Outcome Measures:
  • Transplant related mortality (TRM)
  • Toxicity
  • Adequacy of cell collections
  • Engraftment kinetics

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 69 Years   (Child, Adult, Senior)
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
Information from the National Library of Medicine

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
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

Responsible Party: Laura Johnston, Stanford University School of Medicine
ClinicalTrials.gov Identifier: NCT00186381     History of Changes
Other Study ID Numbers: BMT8N
77045
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: July 27, 2010
Last Verified: July 2010

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