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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


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome

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Trial Information

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.


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 ≥ 18 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*, or HTLV-2* (* at
Canadian centers only)

- Positive pregnancy test or nursing (women of childbearing age only)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Transplant-related mortality (TRM)

Outcome Time Frame:

At 6 months post HSCT

Safety Issue:

No

Principal Investigator

Denis-Claude Roy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Maisonneuve-Rosemont Hospital, Montreal Quebec

Authority:

Canada: Health Canada

Study ID:

CR-AIR-007

NCT ID:

NCT01794299

Start Date:

March 2013

Completion Date:

January 2015

Related Keywords:

  • Acute Myeloid Leukemia
  • Acute Lymphoblastic Leukemia
  • Myelodysplastic Syndrome
  • Haploidentical stem cell transplantation
  • Graft-versus-host disease
  • Immune reconstitution
  • Alloreactive T-cells
  • Photodepletion
  • Photodynamic treatment
  • TH9402
  • Transplant-related mortality
  • Hematologic malignancy
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Hematologic Neoplasms

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