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

• Sponsor: Stanford University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00186381
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Duration (Months): 136
• Patients Per Site Per Month: 1.5

Study Details

Study Description

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

• Study Type: Interventional
• Anticipated 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: Nov 1, 1995
• Actual Primary Completion Date: Mar 1, 2007
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

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

Criteria

• Ages Eligible for Study: 16 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:- must be in remission

• adequate organ function Exclusion Criteria:- prior MDS

• active infection

• liver disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University School of Medicine	Stanford	California	United States	94305

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Laura Johnston, Stanford University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00186381
• Other Study ID Numbers: BMT8N; 77045; BMT8N
• First Posted: Sep 16, 2005
• Last Update Posted: Jul 27, 2010
• Last Verified: Jul 1, 2010

• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Jul 27, 2010