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

July 23, 2010 updated by: Stanford University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:- must be in remission

  • adequate organ function Exclusion Criteria:- prior MDS
  • active infection
  • liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Disease free survival (DFS)

Secondary Outcome Measures

Outcome Measure
Toxicity
Transplant related mortality (TRM)
Adequacy of cell collections
Engraftment kinetics

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Laura Johnston, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 1995

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

July 27, 2010

Last Update Submitted That Met QC Criteria

July 23, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMT8N
  • 77045
  • NCT00186381

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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