Design of the VIALE-M phase III trial of venetoclax and oral azacitidine maintenance therapy in acute myeloid leukemia
FUTURE ONCOLOGY, cilt.18, sa.26, ss.2879-2889, 2022 (SCI-Expanded, Scopus)
- Yayın Türü: Makale / Tam Makale
- Cilt numarası: 18 Sayı: 26
- Basım Tarihi: 2022
- Doi Numarası: 10.2217/fon-2022-0450
- Dergi Adı: FUTURE ONCOLOGY
- Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, CINAHL, EMBASE, MEDLINE
- Sayfa Sayıları: ss.2879-2889
- Anahtar Kelimeler: acute myeloid leukemia, BCL-2 inhibitor, CC-486 (oral azacitidine), first remission, maintenance therapy, minimal residual disease conversion, phase III, relapse-free survival, venetoclax
- Erciyes Üniversitesi Adresli: Evet
Özet
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.