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Clinical trial to evaluate the safety, pharmacokinetics, pharmacodynamics and clinical efficacy of RVU120 in combination with venetoclax in participants with AML in whom previous treatment with venetoclax and a hypomethylating agent failed (RIVER-81).
THE OBJECTIVES OF THIS STUDY ARE TO: ¿ UNDERSTAND THE APPROPRIATE DOSE OF THE STUDY TREATMENT (RVU120 VENETOCLAX) FOR THE SUBSEQUENT STUDY; ¿ UNDERSTAND THE EFFECT OF THE STUDY DRUG IN REDUCING AML; ¿ ASSESS THE TOLERABILITY OF THE STUDY TREATMENT AND IDENTIFY ANY POTENTIAL SIDE EFFECTS ASSOCIATED WITH THE STUDY DRUG; ¿ PERFORM PHARMACOKINETIC (PK) TESTING TO UNDERSTAND HOW THE STUDY TREATMENT IS METABOLIZED AND ELIMINATED FROM THE BODY; ¿ ASSESS HOW THE STUDY TREATMENT AFFECTS THEIR QUALITY OF LIFE; ¿ EVALUATE HOW THE STUDY TREATMENT AFFECTS THEIR QUALITY OF LIFE.
Technical Summary
- OPEN-LABEL, MULTICENTER, DOSE-FINDING CLINICAL TRIAL TO EVALUATE THE SAFETY, PHARMACOKINETICS, PHARMACODYNAMICS, AND CLINICAL EFFICACY OF RVU120 IN COMBINATION WITH VENETOCLAX IN PARTICIPANTS WITH ACUTE MYELOID LEUKEMIA IN WHOM PREVIOUS TREATMENT WITH VENETOCLAX AND A HYPOMETHYLATING AGENT FAILED (RIVER-81).
- Code EudraCT: 2023-505911-19-00
- Protocol number: RIVER-81
- Promoter: Ryvu Therapeutics S.A.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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