A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy (HATCY studie)

A Phase III, multicenter, randomized controlled study to compare safety and efficacy of a haploidentical HSCT and adjunctive treatment with ATIR101, a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells, versus a haploidentical HSCT with post-transplant cyclophosphamide in patients with a hematologic malignancy (HATCY studie) - HATCY study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48941

Enrollment

Registered

2017-06-26

Start date

2017-11-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML and MDS Leukemia/Blood cancer more specifically ALL

Interventions

Patients randomized in the ATIR101 group will receive a single ATIR101 dose of 2×10E6 viable T-cells/kg between 28 and 32 days on top of a T-cell depleted, CD34 selected HSCT. Patients in the PtCY g

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Any of the following hematologic malignancies: - Acute myeloid leukemia (AML) in first cytomorphological remission (with = 70% 5. Male or female, age >= 18 years and = 25 kg and = 16 years and

Exclusion criteria

Exclusion criteria: 1. Diagnosis of chronic myelomonocytic leukemia (CMML) 2. Availability of a suitable HLA-matched sibling or unrelated donor in a donor search 3. Prior allogeneic hematopoietic stem cell transplantation 4. Diffusing capacity for carbon monoxide (hemoglobin corrected DLCO) 2.5 × ULN (CTCAE grade 2) 7. Creatinine clearance

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the study is GVHD-free, relapse-free survival (GRFS). GRFS is defined as time from randomization until grade III/IV acute graft-versus-host disease (GVHD), chronic GVHD requiring systemic immunosuppressive treatment, disease relapse, or death, whichever occurs first. This endpoint captures both safety and efficacy.	—

Secondary

Measure	Time frame
Secondary endpoints: Overall survival (OS) Progression-free survival (PFS) Relapse-related mortality (RRM) Transplant-related mortality (TRM) Immune reconstitution Incidence and severity of acute and chronic GVHD Incidence and severity of viral, fungal, and bacterial infections (efficacy) Incidence and severity of adverse events (safety) Quality of life	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)