Monalizumab treatment for patients with blood cancers undergoing stem cell transplantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of Monalizumab, an anti-NKG2A monoclonal antibody, in patients with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) undergoing haploidentical stem cell transplantation. Participants will receive Monalizumab intravenously on specific days post-transplantation and will be monitored for outcomes such as graft-versus-host disease (GVHD) and progression-free survival. The study aims to enhance immune responses and reduce the risk of disease relapse or GVHD by optimizing the use of this novel antibody.

Why it matters

Who can join: the full rules

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 old, without any restriction of gender and race.
3. Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).
4. 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.
5. 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.
6. Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 8 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.

Exclusion Criteria:

1. Patients aged \< 18 years old.
2. Active uncontrolled infections.
3. 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 allogenic-SCT.
7. Patients who experience acute GVHD before day +30 after allogenic-SCT.
8. Patients treated with a second allogeneic Allo-SCT.

Where it's running

• IRCCS Ospedale Policlinico San Martino
  Genova, Genova, Italy Recruiting
• Irccs Istituto Clinico Humanitas
  Rozzano, Milano, Italy Recruiting

Study contacts

• Study coordinator: Domenico Mavilio, Md
• Email: domenico.mavilio@humanitas.it
• Phone: +39 02 8224 5157

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.