Back to resultsAutologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Primary Purpose
Leukemia, Myelocytic, Acute, Leukemia, Blood and Marrow Transplant (BMT)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
high dose chemotherapy then autologous hematopoietic cell transplant
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myelocytic, Acute
Eligibility Criteria
Inclusion Criteria:- must be in remission adequate organ function Exclusion Criteria:- prior MDS active infection liver disease
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
Disease free survival (DFS)
Secondary Outcome Measures
Transplant related mortality (TRM)
Toxicity
Adequacy of cell collections
Engraftment kinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00186381
Brief Title
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Official Title
Autologous Bone Marrow Transplantation for Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
November 1995 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
Evaluate the role of high dose chemotherapy with autologous hematopoietic cell transplantation for AML.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myelocytic, Acute, Leukemia, Blood and Marrow Transplant (BMT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
high dose chemotherapy then autologous hematopoietic cell transplant
Primary Outcome Measure Information:
Title
Disease free survival (DFS)
Secondary Outcome Measure Information:
Title
Transplant related mortality (TRM)
Title
Toxicity
Title
Adequacy of cell collections
Title
Engraftment kinetics
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:- must be in remission
adequate organ function Exclusion Criteria:- prior MDS
active infection
liver disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Johnston
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Autologous Bone Marrow Transplantation in Acute Non-Lymphoblastic Leukemia During First or Subsequent Remission
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