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).

Study Overview

• Status: Completed
• Conditions: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome

• Study Type: Observational
• Enrollment (Actual): 178

Contacts and Locations

Study Locations

• Belgium
  • Brugge, Belgium, 8000
    • Algemeen Ziekenhuis Sint-Jan
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Leuven, Belgium, 3000
    • Universitair Ziekenhuis Gasthuisberg
• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Niagara Regional Haemophilia Centre
  • Quebec
    • Montreal, Quebec, Canada, H1T 2M4
      • Maisonneuve-Rosemont Hospital
• Germany
  • Würzburg, Germany, 97080
    • Universitätsklinikum Würzburg
• Netherlands
  • Maastricht, Netherlands, 6229 HX
    • Academisch Ziekenhuis Maastricht
• United Kingdom
  • London, United Kingdom, W12 OHS
    • Hammersmith Hospital
• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
HAPLO group; 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; 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; 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; 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?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Kiadis Pharma
• Investigators: Study Chair: Jeroen Rovers, MD, Kiadis Pharma

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 10, 2014
• First Submitted That Met QC Criteria: July 10, 2014
• First Posted (Estimate): July 11, 2014

Study Record Updates

• Last Update Posted (Estimate): October 6, 2015
• Last Update Submitted That Met QC Criteria: October 5, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: Unrelated donor; Graft versus host disease; Hematopoietic Stem Cell Transplantation; Hematologic malignancy; Umbilical cord blood; Transplant-related mortality; Haploidentical donor
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Leukemia, Lymphoid; Myelodysplastic Syndromes; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Other Study ID Numbers: CR-AIR-006