Status:
RECRUITING
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Acute Myeloid Leukaemia
MDS (Myelodysplastic Syndrome)
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
The goal of this clinical trial is to evaluate the effectiveness and safety of the anti-NKG2A monoclonal antibody (Monalizumab) in patients undergoing haploidentical stem cell transplantation (Haplo-S...
Detailed Description
This Phase II non-randomized, open-label, single-arm, monocentric clinical trial aims to evaluate the safety, efficacy, and biological impact of Monalizumab (humZ270 mAb, IPH2201), an anti-NKG2A monoc...
Eligibility Criteria
Inclusion
- Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related procedures.
- Adult patients aged ≥18 years old, without any restriction of gender and race.
- Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).
- Patients lacking a HLA identical donor and receiving haploidentical stem cell transplant with GVHD/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.
- Patient who has received haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a peripheral blood stem cell (PBSC) graft.
- Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 days prior to start of study drug for women of childbearing potential.
- 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
- Patients aged \< 18 years old.
- Active uncontrolled infections.
- CNS involvement of AML disease.
- 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).
- Pregnant or breast-feeding or intending to become pregnant during the study.
- Patients who rapidly relapse after allogenic-SCT before day 30 after allogenic-SCT.
- Patients who experience acute GVHD before day +30 after allogenic-SCT.
- Patients treated with a second allogeneic Allo-SCT.
Key Trial Info
Start Date :
December 3 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT06892223
Start Date
December 3 2021
End Date
December 1 2026
Last Update
March 24 2025
Active Locations (2)
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1
IRCCS Ospedale Policlinico San Martino
Genova, GENOVA, Italy, 16132
2
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy, 20089