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

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ClinicalTrials.gov Identifier: NCT02188290
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : October 6, 2015
Sponsor:
Information provided by (Responsible Party):
Kiadis Pharma

Study Description
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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).

Condition or disease
Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome

Study Design
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Study Type : Observational
Actual Enrollment : 178 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. Transplant-related mortality [ Time Frame: Up to 12 months after the transplantation ]

Secondary Outcome Measures :
  1. Overall survival [ Time Frame: Up to 12 months after the transplantation ]
  2. Incidence of acute and chronic graft versus host disease [ Time Frame: Up to 12 months after the transplantation ]
  3. Progression-free survival [ Time Frame: Up to 12 months after the transplantation ]
  4. Severity of acute and chronic graft versus host disease [ Time Frame: Up to 12 months after the transplantation ]
  5. Relapse-related mortality [ Time Frame: Up to 12 months after the transplantation ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188290


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Belgium
Algemeen Ziekenhuis Sint-Jan
Brugge, Belgium, 8000
Institut Jules Bordet
Brussels, Belgium, 1000
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
Canada, Ontario
Hamilton Niagara Regional Haemophilia Centre
Hamilton, Ontario, Canada, L8N 3Z5
Canada, Quebec
Maisonneuve-Rosemont Hospital
Montreal, Quebec, Canada, H1T 2M4
Germany
Universitätsklinikum Würzburg
Würzburg, Germany, 97080
Netherlands
Academisch Ziekenhuis Maastricht
Maastricht, Netherlands, 6229 HX
United Kingdom
Hammersmith Hospital
London, United Kingdom, W12 OHS
Sponsors and Collaborators
Kiadis Pharma
Investigators
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Study Chair: Jeroen Rovers, MD Kiadis Pharma
More Information
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Responsible Party: Kiadis Pharma
ClinicalTrials.gov Identifier: NCT02188290    
Other Study ID Numbers: CR-AIR-006
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: October 2015
Keywords provided by Kiadis Pharma:
Haploidentical donor
Unrelated donor
Umbilical cord blood
Graft versus host disease
 Transplant-related mortality
Hematologic malignancy
Hematopoietic Stem Cell Transplantation
Additional relevant MeSH terms:
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Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Myelodysplastic Syndromes
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
 Hematologic Diseases
Leukemia, Lymphoid
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases