Patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical transplantation with posttransplantation cyclophosphamide. MedDRA version: 21.1 Level: PT Classification code 10000880 Term: Acute myeloid leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10028533 Term: Myelodysplastic syndrome System Organ Class: 10029104 - Neoplasms benign, malignant and unspe
Conditions
Interventions
Product Name: Monalizumab
Product Code: [IPH2201]
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: Monalizumab
CAS Number: 1228763-95-8
Current Sponsor
Sponsors
IRCCS ISTITUTO CLINICO HUMANITAS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures. 2) Adult patients aged =18 years and =70 years old, without any restriction of gender and race. 3) Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS). 4) Patients lacking a human leukocyte antigen (HLA) identical donor and receiving Haplo-SCT with GVHD/host versus graft (HVG) prophylaxis consisting of Cyclophosphamide: 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. 5) 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. 6) Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential. 7) 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. 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 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: 1) Patients aged 70 years old. 2) Active uncontrolled infections. 3) Central nervous system (CNS) involvement of AML disease. 4) 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). 5) Pregnant or breast-feeding or intending to become pregnant during the study. 6) Patients who rapidly relapse after allogenic-SCT before day 30 after Haplo-SCT. 7) Patients who experience acute GVHD before day +30 after Haplo-SCT. 8) Patients treated with a second allogeneic Allo-SCT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy and safety of Monalizumab after Haplo-SCT with PT-Cy.;Secondary Objective: Evaluate the effect of monalizumab on the immunological reconstitution and other clinical parameters of survival and toxicity.;Primary end point(s): To evaluate the efficacy and safety of NKG2A blockade by Monalizumab after Haplo-SCT with PTCy in terms of GPFS.;Timepoint(s) of evaluation of this end point: 1 year. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Clinical Objectives: Evaluate the incidence of OS, PFS, NRM and post-transplant viral infections in patients receiving Monalizumab after Haplo-SCT. Biological Objectives: Evaluate the reconstitution and alloreactive functions of NK cell population against leukemic cells after Monalizumab administration.;Timepoint(s) of evaluation of this end point: 1 year. | — |
Countries
Italy
Contacts
Public ContactData Manager U.O Ematologia
IRCCS Istituto Clinico Humanitas
Outcome results
None listed