Back to resultsAllo BMT in Advanced Leukemia or High Grade Lymphoma
Primary Purpose
Lymphoma, Non-Hodgkin, Leukemia, Blood and Marrow Transplant (BMT)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ablative allogeneic hematopoietic cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma, Non-Hodgkin
Eligibility Criteria
Inclusion Criteria:HLA identical donor adequate organ function other life threatening disease
Sites / Locations
- Stanford University School of Medicine
Outcomes
Primary Outcome Measures
overall survival
disease free survival
Secondary Outcome Measures
early and late toxicities of the treatment regimen
Full Information
NCT ID
NCT00186290
First Posted
September 13, 2005
Last Updated
October 7, 2010
Sponsor
Stanford University
1. Study Identification
Unique Protocol Identification Number
NCT00186290
Brief Title
Allo BMT in Advanced Leukemia or High Grade Lymphoma
Official Title
Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients With Advanced Leukemia or High Grade Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
December 1989 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Stanford University
4. Oversight
5. Study Description
Brief Summary
To evaluate the role of ablative allogeneic hematopoietic cell transplantation in the treatment of advanced leukemia or lymphoma.
Detailed Description
To determine the disease free survival and overall survival of patients with ALL and ANLL after induction failure, in relapse, or subsequent remission from CML in several phases or recurrent lymphoblastic lymphoma who receive fractionated TBI, etoposide and cyclophosphamide followed by allogenic bone marrow grafting from histocompatible sibling donors. Fractionated Total Body Irradiation (FTBI), Etoposide (VP-16) and Cyclophosphamide (CY) Followed by Allogeneic Bone Marrow Transplantation for Patients with Advanced Leukemia or High Grade Lymphoma
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin, Leukemia, Blood and Marrow Transplant (BMT), Lymphomas: Non-Hodgkin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
145 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
ablative allogeneic hematopoietic cell transplantation
Primary Outcome Measure Information:
Title
overall survival
Time Frame
october 2009
Title
disease free survival
Time Frame
October 2009
Secondary Outcome Measure Information:
Title
early and late toxicities of the treatment regimen
Time Frame
October 2009
10. Eligibility
Sex
All
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:HLA identical donor
adequate organ function
other life threatening disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Lowsky
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
Allo BMT in Advanced Leukemia or High Grade Lymphoma
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