Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
| Status: | Completed |
|---|---|
| Conditions: | Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Blood Cancer, Hematology |
| Therapuetic Areas: | Hematology, Oncology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | September 2014 |
| End Date: | June 2015 |
An Observational Cohort Study on Transplant-Related Mortality in Patients Receiving Either a Hematopoietic Stem Cell Transplantation Without ATIR or an Umbilical Cord Blood Transplantation
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).
data for patients treated with ATIR in clinical studies (e.g. study CR-AIR-007).
Inclusion Criteria:
- 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 Criteria:
- Allogeneic stem cell transplantation prior to the transplantation qualifying for the
study.
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