Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia

Ivanov V., Yeh S., Mayer J., Saini L., ÜNAL A., Boyiadzis M., ...More

Future Oncology, vol.18, no.26, pp.2879-2889, 2022 (SCI-Expanded) identifier identifier identifier

  • Publication Type: Article / Review
  • Volume: 18 Issue: 26
  • Publication Date: 2022
  • Doi Number: 10.2217/fon-2022-0450
  • Journal Name: Future Oncology
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CINAHL, EMBASE, MEDLINE
  • Page Numbers: pp.2879-2889
  • Keywords: acute myeloid leukemia, BCL-2 inhibitor, CC-486 (oral azacitidine), first remission, maintenance therapy, minimal residual disease conversion, phase III, relapse-free survival, venetoclax, QUALITY-OF-LIFE, HEMATOPOIETIC-CELL TRANSPLANTATION, CONVENTIONAL CARE REGIMENS, LOW-DOSE CYTARABINE, OLDER PATIENTS, COMPLETE REMISSION, ELDERLY-PATIENTS, POSTREMISSION TREATMENT, TREATMENT OUTCOMES, BCL-2 INHIBITION
  • Kayseri University Affiliated: No

Abstract

© 2022 The Authors.Prevention of relapse is a major therapeutic challenge and an unmet need for patients with acute myeloid leukemia (AML). Venetoclax is a highly selective, potent, oral BCL-2 inhibitor that induces apoptosis in AML cells. When combined with azacitidine, it leads to prolonged overall survival and rapid, durable remissions in treatment-naive AML patients ineligible for intensive chemotherapy. VIALE-M is a randomized, double-blind, two-arm study to evaluate the safety and efficacy of venetoclax in combination with oral azacitidine (CC-486) as maintenance therapy in patients in complete remission with incomplete blood count recovery after intensive induction and consolidation therapies. The primary end point is relapse-free survival. Secondary outcomes include overall survival, minimal residual disease conversion and improvement in quality-of-life.