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Completed

NCT Number: NCT02188290

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

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).

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Key information

Conditions

Acute Myeloid Leukemia Acute Lymphoblastic Leukemia Bone Marrow Diseases Graft vs Host Disease Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Leukemia, Myeloid Leukemia, Myeloid, Acute Lymphatic Diseases Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Neoplasms by Site Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Algemeen Ziekenhuis Sint-Jan, Bruges, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Transplant-related mortality

    Time frame: Up to 12 months after the transplantation

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Kiadis Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 11, 2014
Registry last updated
Oct 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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