Status:
COMPLETED
Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
Lead Sponsor:
Kiadis Pharma
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Brief Summary
Study CR-AIR-006 is a part of the ATIR clinical development plan and will provide control data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
Eligibility Criteria
Inclusion
- Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in remission at the time of the transplantation
- Acute lymphoblastic leukemia (ALL) in remission at the time of the transplantation
- Myelodysplastic syndrome (MDS)
- Patient received any of the following transplantations:
- Allogeneic T-cell depleted HSCT without ATIR administration from a haploidentical donor between 1 January 2006 and 30 June 2013 (HAPLO group)
- Allogeneic HSCT from a fully matched or 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 (MUD/MMUD groups)
- Double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 with no more than 2 human leukocyte antigen (HLA)-mismatches at HLA-A, B, and/or -DR between each of the units and the recipient (UCB group)
- Male or female, age ≥ 18, ≤ 65 years.
Exclusion
- Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT02188290
Start Date
September 1 2014
End Date
June 1 2015
Last Update
October 6 2015
Active Locations (9)
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1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
2
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium, 8000
3
Institut Jules Bordet
Brussels, Belgium, 1000
4
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000