Back to resultsAutologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
Primary Purpose
Leukemia, Monocytic, Acute
Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Monocytic, Acute focused on measuring AML in 1st & 2nd complete remission w/no HLA matched related donor
Eligibility Criteria
Inclusion Criteria:
- Patients with AML in 1st & 2nd complete remission w/no HLA matched related donor
Sites / Locations
- KFSH&RC
Outcomes
Primary Outcome Measures
Efficacy
Secondary Outcome Measures
Full Information
NCT ID
NCT00531583
First Posted
September 17, 2007
Last Updated
January 4, 2016
Sponsor
King Faisal Specialist Hospital & Research Center
1. Study Identification
Unique Protocol Identification Number
NCT00531583
Brief Title
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
Official Title
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
March 2001 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Faisal Specialist Hospital & Research Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation program for pts w/AML in 1st & 2nd complete remission w/no HLA matched related donor
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Monocytic, Acute
Keywords
AML in 1st & 2nd complete remission w/no HLA matched related donor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
350 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Autologous peripheral Bld Stem Cell Transplantation with In Vivo Purging as an alternate stem cell transplantation
Intervention Description
Autologous PBSCT
Primary Outcome Measure Information:
Title
Efficacy
Time Frame
2009-2015
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with AML in 1st & 2nd complete remission w/no HLA matched related donor
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fahad AlMohareb
Organizational Affiliation
KFSH&RC
Official's Role
Principal Investigator
Facility Information:
Facility Name
KFSH&RC
City
Riyadh
ZIP/Postal Code
1211
Country
Saudi Arabia
12. IPD Sharing Statement
Learn more about this trial
Autologous Peripheral Blood Stem Cell Transplantation With In Vivo Purging as an Alternate Stem Cell Transplantation Program for Pts w/AML in 1st & 2nd Complete Remission w/no HLA Matched Related Donor
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