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Clinical trial of venetoclax and oral azacitidine compared to oral azacitidine in patients with acute myeloid leukemia in first remission

THE PURPOSE OF THIS STUDY IS TO DETERMINE WHICH DOSE OF VENETOCLAX IN COMBINATION WITH AZACITIDINE (AZA, SUBCUTANEOUS OR INTRAVENOUS ADMINISTRATION) IS SAFE AND EFFECTIVE AS MAINTENANCE THERAPY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA IN FIRST REMISSION AFTER CONVENTIONAL INDUCTION AND CONSOLIDATION CHEMOTHERAPY. THIS STUDY WILL ALSO DETERMINE THE DOSE OF VENETOCLAX IN COMBINATION WITH CC-486 (AZACITIDINE ADMINISTERED ORALLY, ORAL AZA¿) THAT CAN BE SAFELY ADMINISTERED AS MAINTENANCE THERAPY IN PATIENTS WITH AML IN FIRST REMISSION AFTER CONVENTIONAL CHEMOTHERAPY (INDUCTION AND CONSOLIDATION) AND EVALUATE THE SAFETY AND EFFICACY OF VENETOCLAX IN COMBINATION WITH CC-486 (ORAL AZA) COMPARED TO PLACEBO CC-486 (ORAL AZA).

Status
In recruitment
headquarters
Pamplona

Technical Summary

  • PHASE 3, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF TWO TREATMENT GROUPS, VENETOCLAX AND ORAL AZACITIDINE COMPARED TO ORAL AZACITIDINE, AS MAINTENANCE THERAPY IN PATIENTS WITH ACUTE MYELOID LEUKEMIA IN FIRST REMISSION AFTER RECEIVING CONVENTIONAL CHEMOTHERAPY (VIALE-M)
  • Code EudraCT: 2019-002217-19
  • Protocol number: M19-708
  • Promoter: Abbvie Spain SLU
  • Link to Clinical Trials

* 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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