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New treatment option for Acute Myeloid Leukaemia
Official title Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
ClinicalTrials.gov ID: NCT06892223
What this study is testing
What is Monalizumab (anti-NKG2A monoclonal antibody)?
Monalizumab (anti-NKG2A monoclonal antibody) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukaemia.
Also referred to as humZ270, mAb IPH2201.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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-SCT) with post-transplantation cyclophosphamide (PT-Cy). The main questions this trial aims to answer are: Does Monalizumab improve graft-versus-host disease-free and progression-free survival (GPFS) in patients after Haplo-SCT?
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- Patients capable of providing informed consent according to ICH/ GCP, and national/local regulations and be willing to comply with all study-related...
- 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...
- Patients lacking a HLA identical donor and receiving haploidentical stem cell transplant with GVHD/HVG prophylaxis consisting of Cyclophosphamide: 40...
- Patient who has received haplo-SCT with a myeloablative or reduced intensity or nonmyeloblative conditioning followed, either by a bone marrow or a...
You likely can't join if
- 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...
- 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.
See the full eligibility criteria
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Genova, GENOVA, Italy
- Rozzano, MILANO, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Genova, GENOVA, Italy; Rozzano, MILANO, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.