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

K

Kiadis Pharma

Status and phase

Completed
Phase 2

Conditions

Acute Lymphoblastic Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia

Treatments

Biological: ATIR

Study type

Interventional

Funder types

Industry

Identifiers

NCT01794299
2012-004461-41 (EudraCT Number)
File # 9427-K0980\1-21C (Other Identifier)
CR-AIR-007

Details and patient eligibility

About

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.

Full 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.

Enrollment

31 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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 human leukocyte antigen (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 West Nile virus (WNV)* (if tested) (* at Canadian centers only)
  • Positive pregnancy test or nursing (women of childbearing age only)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

31 participants in 1 patient group

ATIR
Experimental group
Treatment:
Biological: ATIR

Trial contacts and locations

8

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Data sourced from clinicaltrials.gov

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