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

NCT02188290 | Completed

• 1 other identifier: CR-AIR-006
• Study Type: observational
• Target: 178
• Locations: 6 countries
• Sites: 9

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).

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

Outcome Measures

Primary Outcomes (1)

• Transplant-related mortality

  Up to 12 months after the transplantation

Secondary Outcomes (5)

• 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

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Allogeneic stem cell transplantation prior to the transplantation qualifying for the study.

Sponsors & Collaborators

• Kiadis Pharma: lead

Study Sites (9)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Algemeen Ziekenhuis Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Gasthuisberg

Leuven, 3000, Belgium

Location

Hamilton Niagara Regional Haemophilia Centre

Hamilton, Ontario, L8N 3Z5, Canada

Location

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

Location

Universitätsklinikum Würzburg

Würzburg, 97080, Germany

Location

Academisch Ziekenhuis Maastricht

Maastricht, 6229 HX, Netherlands

Location

Hammersmith Hospital

London, W12 OHS, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes; Graft vs Host Disease; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Bone Marrow Diseases; Neoplasms by Site

Study Officials

• Jeroen Rovers, MD

  Kiadis Pharma

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2014
• First Posted: July 11, 2014
• Study Start: September 1, 2014
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

DE (1); GB (1); NL (1); US (1); CA (2); BE (3)