MONALIZUMAB for Acute myeloid leukemia | Myelodysplastic syndrome | Myelodysplastic/myeloproliferative neoplasm

Inclusion criteria

• {"criterion_text":"- Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures.\n- Adult patients aged =18 yearsold, without any restriction of gender and race.\n- Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).\n- Patients lacking a human leukocyte antigen (HLA) identical donor and receiving Haplo- SCT with GVHD/host versus graft (HVG) prophylaxis consisting of Cyclophosphamide: 40 or 50 mg/kg/day, day +3 and +4, Cyclosporine A: 3 mg/kg/day from day +5, Mycophenolate mofetil: 45 mg/kg/day, from day +5 to day +35.\n- Patient who have received Haplo-SCT with a myeloablative (MA) or reduced intensity (RIC) or non-myeloblative (NMA) conditioning followed either by a bone marrow or a peripheral blood stem cell (PBSC) graft.\n- Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.\n- Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the last dose of study therapy. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 52 weeks after the patient receives his last dose of study therapy contraception."}

Exclusion criteria

• {"criterion_text":"- Patients aged < 18.\n- Active uncontrolled infections.\n- Central nervous system (CNS) involvement of AML disease.\n- Karnofsky performance status (KPS) <60% or severe organ dysfunction, including a left ventricular ejection fraction <40%, DLCO <50% or creatinine clearance <50 ml/min (as per transplant eligibility).\n- Pregnant or breast-feeding or intending to become pregnant during the study.\n- Patients who rapidly relapse after allogenic-SCT before day 30 after Haplo-SCT.\n- Patients who experience acute GVHD before day +30 after Haplo-SCT.\n- Patients treated with a second allogeneic Allo-SCT."}

Primary endpoints

• {"endpoint_text":"- To evaluate the efficacy and safety of NKG2A blockade by Monalizumab after Haplo-SCT with PTCy in terms of GPFS.","definition_or_measurement_approach":"GPFS (graft versus host disease free and progression free survival) at 1 year after Haplo-SCT."}

Secondary endpoints

• {"endpoint_text":"- Clinical Objectives: Evaluate the incidence of OS, PFS, NRM and post-transplant viral infections in patients receiving Monalizumab after Haplo-SCT.","definition_or_measurement_approach":"Evaluate incidence of Overall Survival (OS), Progression Free Survival (PFS), Non-Relapse Mortality (NRM), post-transplant viral infections, and acute and chronic GVHD as clinical outcome measures."}
• {"endpoint_text":"- Biological Objectives: Evaluate the reconstitution and alloreactive functions of NK cell population against leukemic cells after Monalizumab administration.","definition_or_measurement_approach":"Assess NK cell reconstitution and alloreactive function against leukemic cells following Monalizumab administration (biological/immunological endpoints)."}

Italy

Earliest CTIS Part Ii Submission Date

13-09-2024

Latest Decision Or Authorization Date

17-03-2025

Processing Time Days

185

Number Of Sites

2

Number Of Participants

42

Primary sponsor

Full Name

Humanitas Mirasole S.p.A.

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy