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
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Condition or disease |
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Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Myelodysplastic Syndrome |
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 |

Group/Cohort |
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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
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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
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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
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UCB group
Control group of eligible patients who received a double umbilical cord blood transplantation between 1 January 2010 and 31 December 2012
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- Transplant-related mortality [ Time Frame: Up to 12 months after the transplantation ]
- Overall survival [ Time Frame: Up to 12 months after the transplantation ]
- Incidence of acute and chronic graft versus host disease [ 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 ]

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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 |
Inclusion Criteria:
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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)
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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.

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
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 |
Study Chair: | Jeroen Rovers, MD | Kiadis Pharma |
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 |
Haploidentical donor Unrelated donor Umbilical cord blood Graft versus host disease |
Transplant-related mortality Hematologic malignancy Hematopoietic Stem Cell Transplantation |
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 |