Randomized phase 2 trial of CPX-351 vs. CLAG-M (cladribine, cytarabine, G-CSF, and mitoxantrone) for medically unfit adults with acute myeloid leukemia or other high-grade myeloid neoplasms.
Anna B Halpern, Megan Othus, Mary-Elizabeth M Percival et al.
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In 30 seconds
This randomized phase 2 trial evaluated CPX-351 versus CLAG-M in 60 medically unfit adults with untreated acute myeloid leukemia (AML). The primary endpoint of 3-month overall survival (OS) was met by CLAG-M, achieving 70% compared to 60% for CPX-351 (P = 0.41). Although CLAG-M showed a higher complete remission rate, no significant differences in relapse-free survival or overall survival were observed between the two treatments.
Key findings
- CLAG-M achieved a 70% 3-month overall survival compared to 60% for CPX-351 (P = 0.41).
- CLAG-M was associated with a higher complete remission rate of 73% versus 47% for CPX-351 (P = 0.064).
- In patients with proliferative disease, OS was significantly longer with CLAG-M at 18.5 months compared to 3.9 months for CPX-351 (P = 0.02).
Why it matters
The findings highlight the importance of treatment selection in medically unfit adults with AML, particularly the potential benefit of intensive therapy in specific patient subsets. Understanding these outcomes can guide clinicians in making informed treatment decisions.