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Monalizumab infusion in patients with acute myeloid leukemia or myelodysplastic syndrome undergoing haploidentical hematopoietic stem cell transplantation: a phase II clinical trial
EU CTIS ID: 2024-516974-31-00
What this study is testing
Evaluate the efficacy and safety of Monalizumab after Haplo-SCT with PT-Cy.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
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 procedures.
- Adult patients aged =18 yearsold, without any restriction of gender and race.
- Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).
- 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.
- 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.
- Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 days prior to start of study drug for women of childbearing potential.
You likely can't join if
- Patients aged < 18.
- Active uncontrolled infections.
- Central nervous system (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 Haplo-SCT.
See the full eligibility criteria
Who can join
- 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 yearsold, without any restriction of gender and race.
- Patients with a hematologic malignancy represented either by Acute Myeloid Leukemia or Myelodysplastic Syndrome (MDS) or Myelodysplastic syndrome/Myeloproliferative neoplasm (MDS/MPN).
- 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.
- 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.
- Negative beta-human chorionic gonadotropin (ß-HCG) pregnancy test within 7 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.
What rules you out
- Patients aged < 18.
- Active uncontrolled infections.
- Central nervous system (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 Haplo-SCT.
- Patients who experience acute GVHD before day +30 after Haplo-SCT.
- Patients treated with a second allogeneic Allo-SCT.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.