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NK Cell Infusion Post-Haploidentical HSCT in AML and MDS
NCT04166929Phase 2
Key facts
- Status
- Terminated
- Start
- Jan 2020
- Primary completion
- Sep 2023
- Countries
- 1
- Sponsor
- Policlinico Gemelli
- Modality
- Lymphokine-Activated Killer Cells, CAR-NK Cells
- Drugs
- Natural Killer Cells
- Conditions
- acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)
01
Overview
Phase 2, randomised, open-label trial of Natural Killer Cells in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) (2 arms), sponsored by Policlinico Gemelli. Primary endpoint: Leukemia relapse at 1 year. Started Jan 2020; status: terminated.
02
Design
2 arms- Study design
- RandomizedOpen-label
Haplo-SCT + NK Cells
Haplo-SCT followed by NK cell infusion on Day +7
Haplo-SCT
Standard Haplo-SCT without NK cell boost
03
Who it enrols
Patients with AML or MDS not in remission, aged 18-75, with an available haploidentical donor eligible for both marrow and lymphocyte donation.
04
Endpoints
Primary
Leukemia relapse
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