Clinical trial NCT02188290: Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
Official title: 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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Keywords: Haploidentical donor
Unrelated donor
Umbilical cord blood
Graft versus host disease
Transplant-related mortality
Hematologic malignancy
Hematopoietic Stem Cell Transplantation
Lead sponsor: Kiadis Pharma
Sponsor class: INDUSTRY
First posted: 2014-07-11
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients having received a haploidentical hematopoietic stem cell transplantation (HSCT) between 1 January 2006 and 30 June 2014, an HSCT from an unrelated donor between 1 January 2010 and 31 December 2012, or a double UCB transplantation between 1 January 2010 and 31 December 2012 will be selected from the centers that enrolled patients in study CR-AIR-004 and/or study CR-AIR-007.

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Transplant-related mortality
timeFrame: Up to 12 months after the transplantation
Secondary outcomes:
measure: Overall survival
timeFrame: Up to 12 months after the transplantation
measure: Incidence of acute and chronic graft versus host disease
timeFrame: Up to 12 months after the transplantation
measure: Progression-free survival
timeFrame: Up to 12 months after the transplantation
measure: Severity of acute and chronic graft versus host disease
timeFrame: Up to 12 months after the transplantation
measure: Relapse-related mortality
timeFrame: Up to 12 months after the transplantation
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Brugge
country: Belgium
facility: Algemeen Ziekenhuis Sint-Jan
city: Brussels
country: Belgium
facility: Institut Jules Bordet
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Gasthuisberg
city: Hamilton
country: Canada
facility: Hamilton Niagara Regional Haemophilia Centre
state: Ontario
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht
city: London
country: United Kingdom
facility: Hammersmith Hospital
Study officials:
affiliation: Kiadis Pharma
name: Jeroen Rovers, MD
role: STUDY_CHAIR
References: