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 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, and every 2 months from 6 until 12 months after
the HSCT.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Transplant-related mortality (TRM)
At 6 months post HSCT
No
Denis-Claude Roy, MD
Study Chair
Maisonneuve-Rosemont Hospital, Montreal Quebec
Canada: Health Canada
CR-AIR-007
NCT01794299
March 2013
January 2015
Name | Location |
---|