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New Protocol: Venetoclax Added to Cladribine + Cytarabine alternating with Azacytidine for newly diagnosed AML in Elderly

New Protocol: Venetoclax Added to Cladribine + Cytarabine alternating with Azacytidine for newly diagnosed AML in Elderly
Study:
  • Phase II trial – Newly diagnosed AML (excluding APL, CBF) in pts >= 60 yrs
  • Induction with Cladribine + low-dose subQ cytarabine x 1-2 cycles + Venetoclax
  • Consolidation with cladribine + low-dose subQ cytarabine x 2 cycles alternating with azacytidine x 2 cycles, all cycles combined with venetoclax (21/28d), max 18 cycles (n=48)
Efficacy:
  • CR/CRi: 94%
  • Median RFS: NR, 12-month RFS: 64%
  • Median OS: NR, 12-month OS: 70%
Safety:
  • Grade >=3 non-heme AEs: Neutropenic fever (42%), lung infection (19%)

Presented at: 62nd ASH Annual Meeting; December 5, 2020. Abstract 616.

Kadia TM, et al. Phase II Study of Venetoclax Added to Cladribine + Low Dose AraC (LDAC) Alternating with 5-Azacytidine Demonstrates High Rates of Minimal Residual Disease (MRD) Negative Complete Remissions (CR) and Excellent Tolerability in Older Patients with Newly Diagnosed Acute Myeloid Leukemia (AML)

https://ash.confex.com/ash/2020/webprogram/Paper142092.html

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