Patients with a hematologic malignancy (AML, ALL, or MDS) who are eligible for a haploidentical HSCT 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: LLT Classification code 10059044
Conditions
Interventions
Product Name: ATIR101 (previously referred to as ATIR)
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: -
CAS Number: -
C
Sponsors
Kiadis Pharma Netherlands B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria: • Availability of a fully matched related or unrelated donor following a donor search • Diffusing capacity for carbon monoxide (DLCO) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to study the safety and efficacy of a repeat dose administration of ATIR101 in patients with a hematologic malignancy who received a T-cell depleted haploidentical HSCT.;Secondary Objective: Not applicable;Primary end point(s): Incidence of acute graft versus host disease (GvHD) grade III/IV up to 180 days post HSCT.;Timepoint(s) of evaluation of this end point: At 180 days post HSCT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Incidence and severity of acute and chronic graft versus host disease (GvHD) • Time to T-cell reconstitution, defined as the time to CD3+ in peripheral blood higher than 0.2×109/L (at two consecutive measurements; time to first measurement) • Incidence and severity of viral, fungal, and bacterial infections • Transplant-related mortality (TRM), defined as death due to causes other than disease relapse or progression, or other causes which are unrelated to the transplantation procedure (e.g. accident, suicide) • Relapse-related mortality (RRM), defined as death due to disease relapse or disease progression • Overall survival (OS), defined as the time from HSCT until death from any cause • Progression-free survival (PFS), defined as the time from HSCT until relapse, disease progression, or death, whichever occurs first • GvHD-free, relapse-free survival (GRFS), defined as the time until acute GvHD grade III/IV, chronic GvHD requiring systemic treatment, relapse, or death, whichever occurs first ;Timepoint(s) of evaluation of this end point: Up to 12 months post HSCT | — |
Countries
Belgium, Canada, Croatia, Germany, Portugal, United Kingdom
Contacts
Public ContactClinical Trial Information
Kiadis Pharma Netherlands B.V.
Outcome results
None listed