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December 8, 2025BloodOpen Access

Combination of CPX-351 and gemtuzumab ozogamicin (GO) in relapsed/refractory (R/R) Acute Myeloid Leukemia and post-hypomethylating agent (HMA) failure high-risk myelodysplastic syndrome (HR-MDS)

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Authors

CDCourtney DiNardoEJElias JabbourGBGautam Borthakur

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Overview

Pilot study shows modest activity of CPX-351 and gemtuzumab ozogamicin in R/R myeloid malignancies, indicating potential therapeutic options.

Key Points

  • To evaluate the efficacy and safety of the combination of CPX-351 and gemtuzumab ozogamicin in relapsed/refractory AML and high-risk MDS after hypomethylating agent failure.
  • Single-arm pilot study evaluated CPX-GO in patients with CD33+ R/R AML or post-HMA failure HR-MDS.
  • Induction therapy consisted of CPX-351 plus gemtuzumab ozogamicin on specified days.
  • Patients received re-induction and consolidation cycles based on response, with overall survival and progression-free survival assessed.
  • Overall response rate was 30%, with complete remission and partial remission observed.
  • Median overall survival was 4.8 months, with responders having a median overall survival of 9.7 months.
  • Most common adverse events included febrile neutropenia, sepsis, and pneumonia.

Cite This Study

DiNardo et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e3cchttps://doi.org/10.1182/blood-2025-1688
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Also Consider

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

  1. 1Initial results from a phase 2 study of cladribine, cytarabine, and granulocyte-colony stimulating factor with gemtuzumab ozogamicin (CLAG-GO) for the treatment of patients with relapsed/refractory acute myeloid leukemia2025
  2. 2Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients2024 · 2 citations
  3. 3Real-world evidence evaluation of the safety and efficacy of intensive chemotherapy with or without gemtuzumab ozogamicin (GO) in patients with newly diagnosed Acute Myeloid Leukemia (AML) and favorable or intermediate risk cytogenetics2025
  4. 4Safety outcomes in patients with acute myeloid leukemia receiving gemtuzumab ozogamicin and proceeding to allogeneic hematopoietic stem cell transplantation.2024
  5. 5Safety outcomes in adult patients with AML who achieved their first complete remission with GO prior to HSCT.2024