Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Myelodysplastic Syndrome
Conditions
Keywords
Haploidentical donor, Unrelated donor, Umbilical cord blood, Graft versus host disease, Transplant-related mortality, Hematologic malignancy, Hematopoietic Stem Cell Transplantation
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).
Interventions
None listed
Sponsors
Kiadis Pharma
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Transplant-related mortality | Up to 12 months after the transplantation |
Secondary
| Measure | Time frame |
|---|---|
| Severity of acute and chronic graft versus host disease | Up to 12 months after the transplantation |
| Relapse-related mortality | Up to 12 months after the transplantation |
| Overall survival | Up to 12 months after the transplantation |
| Incidence of acute and chronic graft versus host disease | Up to 12 months after the transplantation |
| Progression-free survival | Up to 12 months after the transplantation |
Countries
Belgium, Canada, Germany, Netherlands, United Kingdom, United States
Outcome results
None listed