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Register:	ClinicalTrials.gov
Last refreshed on:	19 October 2015
Main ID:	NCT02188290
Date of registration:	10/07/2014
Prospective Registration:	Yes
Primary sponsor:	Kiadis Pharma
Public title:	Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation
Scientific 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
Date of first enrolment:	September 2014
Target sample size:	178
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02188290
Study type:	Observational
Study design:	Observational Model: Cohort, Time Perspective: Retrospective
Phase:	N/A

Countries of recruitment
Belgium	Canada	Germany	Netherlands	United Kingdom	United States

Contacts

Name:	Jeroen Rovers, MD
Address:
Telephone:
Email:
Affiliation:	Kiadis Pharma

Key inclusion & exclusion 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.

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Acute Lymphoblastic Leukemia

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Intervention(s)

Primary Outcome(s)

Transplant-related mortality [Time Frame: Up to 12 months after the transplantation]

Secondary Outcome(s)

Incidence of acute and chronic graft versus host disease [Time Frame: Up to 12 months after the transplantation]

Overall survival [Time Frame: Up to 12 months after the transplantation]

Progression-free survival [Time Frame: Up to 12 months after the transplantation]

Severity of acute and chronic graft versus host disease [Time Frame: Up to 12 months after the transplantation]

Relapse-related mortality [Time Frame: Up to 12 months after the transplantation]

Secondary ID(s)

CR-AIR-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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