Safety and efficacy of two doses of ATIR101, a T-lymphocyte enriched leukocyte preparation depleted of host alloreactive T-cells, in patients with a hematologic malignancy who received a hematopoietic stem cell transplantation from a haploidentical donor

Phase 1

• Conditions: Patients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCT; MedDRA version: 19.1 Level: LLT Classification code 10059044 Term: Allogeneic peripheral hematopoietic stem cell transplant System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10027703 Term: Mismatched donor bone marrow transplantation therapy System Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-002821-20-DE
• Lead Sponsor: Kiadis Pharma Netherlands B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-27
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

• Any of the following hematologic malignancies:
- Acute myeloid leukemia (AML) in first remission with high-risk features or in second or higher remission
- Acute lymphoblastic leukemia (ALL) in first remission with high-risk features or in second or higher remission
- Myelodysplastic syndrome (MDS): transfusion-dependent, or intermediate or higher IPSS-R risk group
• Karnofsky performance status = 70%
• Eligible for haploidentical stem cell transplantation according to the investigator
• Male or female, age = 18 years and = 65 years
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Availability of a fully matched related or unrelated donor following a donor search
• Diffusing capacity for carbon monoxide (DLCO) < 50% predicted
• Left ventricular ejection fraction < 50% (evaluated by echocardiogram or MUGA)
• AST > 2.5 x ULN (CTCAE grade 2)
• Bilirubin > 1.5 x ULN (CTCAE grade 2)
• Creatinine clearance < 50 mL/min (calculated or measured)
• Positive HIV test
• Positive pregnancy test (women of childbearing age only)
• Prior allogeneic HSCT
• Estimated probability of surviving less than 3 months
• Known allergy to any of the components of ATIR101 (e.g., dimethyl sulfoxide)
• Known presence of HLA antibodies against the non-shared donor haplotype
• Any other condition which, in the opinion of the investigator, makes the patient ineligible for the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified