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

Kiadis Pharma

Status: Completed

Conditions: Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome; Acute Myeloid Leukemia

Study type: Observational

Funder types: Industry

Identifiers

NCT02188290

CR-AIR-006

Details and patient eligibility

About

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).

Enrollment: 178 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

178 participants in 4 patient groups

HAPLO group

Description:

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

Description:

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

Description:

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

Description:

Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012