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

Acute Myeloid Leukemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02188290
• Other study ID #: CR-AIR-006
• Status: Completed
• Phase: N/A
• First received: July 10, 2014
• Last updated: October 5, 2015
• Start date: September 2014
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Kiadis Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Preleukemia

Locations

Country	Name	City	State
Belgium	Algemeen Ziekenhuis Sint-Jan	Brugge
Belgium	Institut Jules Bordet	Brussels
Belgium	Universitair Ziekenhuis Gasthuisberg	Leuven
Canada	Hamilton Niagara Regional Haemophilia Centre	Hamilton	Ontario
Canada	Maisonneuve-Rosemont Hospital	Montreal	Quebec
Germany	Universitätsklinikum Würzburg	Würzburg
Netherlands	Academisch Ziekenhuis Maastricht	Maastricht
United Kingdom	Hammersmith Hospital	London
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Kiadis Pharma

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Germany,  Netherlands,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Transplant-related mortality		Up to 12 months after the transplantation	No
Secondary	Overall survival		Up to 12 months after the transplantation	No
Secondary	Incidence of acute and chronic graft versus host disease		Up to 12 months after the transplantation	Yes
Secondary	Progression-free survival		Up to 12 months after the transplantation	No
Secondary	Severity of acute and chronic graft versus host disease		Up to 12 months after the transplantation	Yes
Secondary	Relapse-related mortality		Up to 12 months after the transplantation	No