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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HAPLO group<br>Control group of all eligible patients who received an HSCT from a haploidentical donor without ATIR administration between 1 January 2006 and 30 June 2013 | |
| MUD group<br>Control group of eligible patients who received an HSCT from a fully matched unrelated donor between 1 January 2010 and 31 December 2012 | |
| MMUD group<br>Control group of eligible patients who received an HSCT from a 1-locus mismatched unrelated donor between 1 January 2010 and 31 December 2012 | |
| UCB group<br>Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transplant-related mortality |  | Up to 12 months after the transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Haploidentical donor, Unrelated donor, Umbilical cord blood, Graft versus host disease, Transplant-related mortality, Hematologic malignancy, Hematopoietic Stem Cell Transplantation