CR-AIR-006: An observational cohort study

• Research type

  Research Study

• Full 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

• IRAS ID

  160087

• Contact name

  Dragana Milojkovic

• Contact email

  d.milojkovic@imperial.ac.uk

• Clinicaltrials.gov Identifier

  NA, NA

• Research summary

  Study CR-AIR-006 is a retrospective observational study in which efficacy and safety data will be collected from patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from either a haploidentical family donor or a matched unrelated donor, or who received an umbilical cord blood transplantation. The collected data will be grouped by type of transplantation (haploidentical transplantation, matched unrelated donor transplantation or cord blood transplantation). The data collected in study CR-AIR-006 will serve as external control groups for comparison with data obtained from clinical studies with ATIR.
  ATIR is an individualized cell-based therapy for patients with a hematologic malignancy who received a haploidentical stem cell transplantation. A few clinical studies have been performed to assess the safety and efficacy of ATIR, but all without internal control groups. In order to evaluate the efficacy and safety of ATIR, a control group is needed consisting of patients with similar malignancies, who also received a stem cell transplantation but without the addition of ATIR. Study CR-AIR-006 aims to provide the control group data for comparison with data obtained from clinical studies with ATIR. The patient population of interest in study CR-AIR-006 consists of patients who received a haploidentical stem cell transplantation without ATIR between January 2006 and June 2013, patients who received a hematopoietic stem cell transplantation from a matched unrelated donor between January 2010 and December 2012, and patients who received a double umbilical cord blood transplantation between January 2010 and December 2012. Data will be collected from European/North American transplantation centers that also participated in previous ATIR studies. Study CR-AIR-006 is initiated by Kiadis Pharma and is expected to be completed in Q4 2014.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  14/EM/1099

• Date of REC Opinion

  25 Jul 2014

• REC opinion

  Favourable Opinion