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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Interventions

ATIR

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Denis Claude Roy, Prof MD

Affiliation: Maisonneuve-Rosemont Hospital, Montreal Quebec

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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