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Treatment Intensity in Less Fit AML
NCT03012672Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2016
- Primary completion
- Dec 2020
- Countries
- 1
- Sponsor
- University of Washington
- Modality
- Lipid-based Nanoparticles, CAR-T Cells, Small Molecules
- Drugs
- cladribinecytarabinemitoxantrone hydrochloride liposome injection + fludarabine + CD19 CAR-T cells
- Conditions
- acute myeloid leukemia (AML)myeloid neoplasm
01
Overview
Phase 2, randomised, open-label trial of cladribine, cytarabine and mitoxantrone hydrochloride liposome injection + fludarabine + CD19 CAR-T cells in acute myeloid leukemia (AML) and myeloid neoplasm (2 arms), sponsored by University of Washington. Primary endpoint: Feasibility Defined as Proportion of Patients Willing to be Randomized. Started Dec 2016; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Higher-Dose
Higher dose Cladribine, Cytarabine, Mitoxantrone + G-CSF
Lower-Dose
Lower dose Cladribine, Cytarabine, Mitoxantrone + G-CSF
03
Who it enrols
Medically less fit adults with newly diagnosed AML or high-grade myeloid neoplasm (>=10% blasts), TRM score >= 13.1, and adequate cardiac function.
04
Endpoints
Primary
Feasibility Defined as Proportion of Patients Willing to be Randomized
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