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Brief Title: Safety and Efficacy of Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells (ATIR) in Patients With a Hematologic Malignancy Who Received a Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Official Title: An Exploratory, Open-label, Multicenter Study to Evaluate the Safety and Efficacy of ATIR, Donor T-lymphocytes Depleted ex Vivo of Host Alloreactive T-cells, in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Study ID: NCT01794299
Brief Summary: The purpose of this study is to determine whether ATIR is safe and effective in reducing transplant-related mortality and improving overall survival, when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor.
Detailed Description: Study CR-AIR-007 is an exploratory, open-label, multicenter study. After signing informed consent, patients will receive a hematopoietic stem cell transplantation (HSCT) from a related, haploidentical donor, followed by infusion with ATIR between 28 and 32 days after the HSCT (or later if required by the patient's medical condition). Patients will receive ATIR as a single infusion at a dose of 2x10E6 viable T-cells/kg. All patients treated with ATIR will be followed up until 12 months after the HSCT. Assessments will be performed at weekly visits from the day of ATIR infusion until 8 weeks after ATIR infusion, at monthly visits from 3 until 6 months after the HSCT, every 2 months from 6 until 12 months after the HSCT, and every 6 months from 12 until 24 months after the HSCT.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Université Libre de Bruxelles - Institute Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium
Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
Universitätsklinikum Würzburg, Würzburg, , Germany
Hammersmith Hospital, London, , United Kingdom
Name: Denis Claude Roy, Prof MD
Affiliation: Maisonneuve-Rosemont Hospital, Montreal Quebec
Role: STUDY_CHAIR