Actively Recruiting
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
Led by Istituto Clinico Humanitas · Updated on 2025-03-24
42
Participants Needed
2
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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? * What are the safety and side effects of Monalizumab in this patient group? * How does Monalizumab affect the reconstitution and function of NK cells in patients undergoing Haplo-SCT? * Researchers will administer Monalizumab to participants on day +30 and +44 after transplantation to see if it enhances immune responses and prevents disease relapse or GVHD. Participants will: * Receive Monalizumab intravenously at 1 mg/kg on day +30 and day +44 after Haplo-SCT * Be monitored for clinical outcomes such as GVHD, survival rates, and immune function for up to one year after the transplant * Undergo regular checkups and tests to assess the effectiveness and safety of the treatment
CONDITIONS
Official Title
Anti-NKG2A Monoclonal Antibody for AML or MDS Patients Undergoing Haploidentical Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide informed consent and willing to follow study procedures
- Adults aged 18 years or older
- Diagnosed with Acute Myeloid Leukemia, Myelodysplastic Syndrome, or MDS/MPN
- Receiving haploidentical stem cell transplant with GVHD prophylaxis including cyclophosphamide, cyclosporine A, and mycophenolate mofetil
- Having undergone myeloablative, reduced intensity, or nonmyeloblative conditioning followed by bone marrow or peripheral blood stem cell graft
- Women of childbearing potential with a negative pregnancy test within 8 days before starting study drug
- Women and men with partners of childbearing potential agree to use effective contraception from consent until 52 weeks after last study treatment
You will not qualify if you...
- Under 18 years of age
- Active uncontrolled infections
- Central nervous system involvement of AML
- Karnofsky performance status below 60% or severe organ dysfunction including low heart function, lung capacity, or kidney function
- Pregnant, breastfeeding, or planning pregnancy during the study
- Rapid relapse after allogeneic stem cell transplant before day 30
- Experienced acute graft-versus-host disease before day +30 post-transplant
- Treated with a second allogeneic stem cell transplant
AI-Screening
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Trial Site Locations
Total: 2 locations
1
IRCCS Ospedale Policlinico San Martino
Genova, GENOVA, Italy, 16132
Actively Recruiting
2
Irccs Istituto Clinico Humanitas
Rozzano, MILANO, Italy, 20089
Actively Recruiting
Research Team
D
DOMENICO MAVILIO, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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