Status:
COMPLETED
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
Lead Sponsor:
Kiadis Pharma
Conditions:
Acute Myeloid Leukemia
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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 malign...
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...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2017
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT01794299
Start Date
March 1 2013
End Date
September 1 2017
Last Update
April 12 2021
Active Locations (8)
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1
Algemeen Ziekenhuis Sint-Jan
Bruges, Belgium, 8000
2
Université Libre de Bruxelles - Institute Jules Bordet
Brussels, Belgium, 1000
3
Universitair Ziekenhuis Gasthuisberg
Leuven, Belgium, 3000
4
Juravinski Hospital and Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3