Overview

This trial is active, not recruiting.

Conditions acute myeloid leukemia, acute lymphoblastic leukemia, myelodysplastic syndrome
Treatment atir
Phase phase 2
Sponsor Kiadis Pharma
Start date March 2013
End date June 2016
Trial size 31 participants
Trial identifier NCT01794299, 2012-004461-41, CR-AIR-007, File # 9427-K0980\1-21C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
atir
Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.

Primary Outcomes

Measure
Transplant-related mortality (TRM)
time frame: At 6 months post HSCT

Secondary Outcomes

Measure
Immune reconstitution
time frame: Up to 24 months post HSCT
TRM
time frame: Up to 24 months post HSCT
Relapse-related mortality (RRM)
time frame: Up to 24 months post HSCT
Overall survival (OS)
time frame: Up to 24 months post HSCT
Progression-free survival (PFS)
time frame: Up to 24 months post HSCT
Incidence of viral, fungal, and bacterial infections
time frame: Up to 24 months post HSCT
Severity of viral, fungal, and bacterial infections
time frame: Up to 24 months post HSCT
Incidence of acute and chronic graft versus host disease (GvHD)
time frame: Up to 24 months post HSCT
Severity of acute and chronic GvHD
time frame: Up to 24 months post HSCT

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - Any of the following hematologic malignancies: a) Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission b) Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission c) Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher Revised International Prognostic Scoring System (IPSS-R) risk group - Eligible for haploidentical stem cell transplantation according to the investigator Exclusion Criteria: - Availability of a suitable matched related or unrelated donor following a donor search - In second or higher remission with the previous remission having lasted less than 6 months - Diffusing capacity for carbon monoxide (DLCO) < 50% predicted - Left ventricular ejection fraction < 50% (evaluated by echocardiogram or multiple gated acquisition [MUGA]) - Aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)(CTCAE grade 2) - Bilirubin > 1.5 x ULN (CTCAE grade 2) - Creatinine clearance < 50 mL/min (calculated or measured) - Positive test for human immunodeficiency virus (HIV) - Positive pregnancy test (women of childbearing age only) - Prior allogeneic stem cell transplantation using stem cells from a matched sibling donor, a matched unrelated donor, a haploidentical donor, or a cord blood donor - Prior autologous stem cell transplantation - Stay at intensive care unit for more than 2 months in the preceding 12 months - Estimated probability of surviving less than 3 months - Known allergy to any of the components of ATIR (e.g., dimethyl sulfoxide) - Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study Donor inclusion criteria - Haploidentical family donor with 2 to 3 mismatches at the HLA-A, -B and/or -DR loci of the unshared haplotype - Male or female, age ≥ 16 and ≤ 75 years - Eligible for donation according to the transplantation center Donor exclusion criteria - Positive viral test for HIV-1, HIV-2, hepatitis B virus (HBV), hepatitis C virus (HCV), Treponema pallidum, human T-lymphotropic virus (HTLV)-1*, HTLV-2*, or WNV* (if tested) (* at Canadian centers only) - Positive pregnancy test or nursing (women of childbearing age only)

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by Kiadis Pharma.