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Brief Title: Safety and Efficacy of Two Doses of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted of Host Alloreactive T-cells, 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 a Two-dose Regimen of ATIR101, a T-lymphocyte Enriched Leukocyte Preparation Depleted ex Vivo of Host Alloreactive T-cells (Using Photodynamic Treatment), in Patients With a Hematologic Malignancy, Who Received a CD34-selected Hematopoietic Stem Cell Transplantation From a Haploidentical Donor
Study ID: NCT02500550
Brief Summary: The purpose of this study is to determine whether a repeat dose administration of ATIR101 is safe and effective when infused in patients with a hematologic malignancy following a T-cell depleted stem cell graft from a related haploidentical donor. All patients are planned to receive two ATIR101 doses of 2Ă10E6 viable T-cells/kg, unless the second dose is reduced or halted for safety reasons.
Detailed Description: Study CR-AIR-008 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 a first ATIR101 infusion at a dose of 2Ă10E6 viable T-cells/kg between 28 and 32 days after the HSCT. Patients will receive a second ATIR101 infusion at a dose of 2Ă10E6 viable T-cells/kg between 70 and 74 days after the HSCT. To evaluate safety of the second dose administration, the first 6 patients treated will be evaluated for the occurrence of dose limiting toxicity (DLT), defined as acute GvHD grade III/IV within 120 days post HSCT (or within 42 days after the second ATIR101 infusion in case of prior dose delays). If within the first 6 patients no DLT is observed, treatment of the remaining 9 patients will continue with two ATIR101 doses of 2Ă10E6 viable T cells/kg. If within the first 6 patients at least 2 patients show DLT, the second ATIR101 infusion will be adjusted to a dose of 1Ă10E6 viable T cells/kg. If in one of the next 3 patients treated at this lower dose again DLT is observed, the second ATIR101 infusion will be halted and the remaining patients will be given only a single dose of ATIR101. All patients treated with ATIR101 will be followed up until 12 months after the HSCT. Assessments will be performed at weekly visits from the day of the first ATIR101 infusion (Week 4) until 6 weeks after the second ATIR101 infusion (Week 16), at monthly visits from 4 until 6 months after the HSCT, and every 3 months from 6 until 12 months after the HSCT.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Algemeen Ziekenhuis Sint-Jan, Brugge, , Belgium
Institut Jules Bordet, Brussels, , Belgium
Universitair Ziekenhuis Gasthuisberg, Leuven, , Belgium
Centre Hospitalier Universitaire de Liège, Liège, , Belgium
Juravinski Hospital and Cancer Centre, Hamilton, Ontario, Canada
Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada
University Hospital Centre Zagreb, Zagreb, , Croatia
University Medical Center Mainz, Mainz, , Germany
Hospital de Santa Maria, Clinica Universitaria Hematologia, Lisboa, , Portugal
Heartlands Hospital, Birmingham, , United Kingdom
Hammersmith Hospital, London, , United Kingdom
Name: Denis Claude Roy, Prof MD
Affiliation: Maisonneuve-Rosemont Hospital (Montreal, Canada)
Role: PRINCIPAL_INVESTIGATOR
Name: Stephan Mielke, Prof MD
Affiliation: Centre for Allogeneic Stem Cell Transplantation, Karolinska University Hospital (Stockholm, Sweden)
Role: PRINCIPAL_INVESTIGATOR