Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation

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).

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.