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December 8, 2025Blood

Phase I study of lower dose CPX-351 combined with venetoclax for patients with higher-risk myelodysplastic syndrome or chronic myelomonocytic leukemia after hypomethylating agents failure

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Authors

EJElias JabbourKCKelly S. ChienFRFarhad Ravandi

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Overview

Phase I trial shows safety and efficacy of CPX-351 and venetoclax in high-risk MDS and CMML, indicating potential for allogeneic stem cell transplantation.

Key Points

  • To evaluate safety and efficacy of lower dose CPX-351 combined with venetoclax in patients with HMA-failure high-risk myelodysplastic syndrome or CMML.
  • Conducted phase I/II clinical trial for adults with R/R MDS or MDS/MPN post-HMA failure.
  • Administered CPX-351 combined with VEN in a dose-escalation design to assess MTD.
  • Eligible participants included those with high-risk disease and significant bone marrow blasts.
  • Utilized Bayesian optimal interval design for dose identification.
  • Six patients enrolled with a median age of 68 years; 67% had myelodysplastic syndrome.
  • The overall response rate was 84% after a median of one cycle of therapy, with 50% achieving complete remission.
  • No cases of progression to acute myeloid leukemia or 8-week mortality were reported.
  • Next-generation sequencing showed a reduction in variant allele frequencies in responders.

Cite This Study

Jabbour et al. (2025) studied this question.

synapsesocial.com/papers/69362f4e4fa91c937236d898https://doi.org/10.1182/blood-2025-5645
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Venetoclax and decitabine in myeloproliferative neoplasm-blast Phase (MPN-BP): Results of enable, a gimema and airc-mynerva multicenter, Phase 2 trial2025 · 5 citations
  2. 2A phase I/II trial of azacitidine and venetoclax in previously untreated Myelodysplastic Syndromes2025 · 1 citations
  3. 3Molecular profile linked to resistance to hypomethilating agents plus venetoclax does not predict outcome in secondary Acute Myeloid Leukemia patients receiving CPX-351 induction.2025
  4. 4Phase II study of clinical efficacy of venetoclax in combination with azacitidine in patients with therapy related myelodysplastic syndrome (t-MDS)2025
  5. 5Phase 1 study of venetoclax combined with a 10-day regimen of decitabine in subjects with high-risk acute myeloid leukemia.2026