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December 8, 2025Blood

Initial 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 leukemia

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Authors

DCDung‐Tsa ChenVSVivek M. ShastriSBSøren M. Bentzen

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Overview

Phase II trial demonstrates response rate of CLAG-GO for relapsed/refractory AML, implying manageable toxicity.

Key Points

  • This study aims to evaluate the efficacy and safety of CLAG-GO in patients with relapsed/refractory acute myeloid leukemia.
  • Single-center, single-arm phase II trial
  • Adult patients with AML received G-CSF, cladribine, cytarabine, and gemtuzumab ozogamicin
  • Assessment of complete remission, measurable residual disease, and overall survival
  • Composite complete remission rate of 42% among enrolled patients
  • Median overall survival was 9.53 months with 31.6% alive after 51 months
  • Febrile neutropenia (95%), thrombocytopenia (79%), and anemia (47%) were the most common adverse events

Cite This Study

Chen et al. (2025) studied this question.

synapsesocial.com/papers/69362f764fa91c937236e393https://doi.org/10.1182/blood-2025-999
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Also Consider

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

  1. 1Limited efficacy of 3 + 7 plus gemtuzumab ozogamycin in newly diagnosed fit intermediate genetic risk acute myeloid leukemia patients2024 · 2 citations
  2. 2Real-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
  3. 3Safety outcomes in patients with acute myeloid leukemia receiving gemtuzumab ozogamicin and proceeding to allogeneic hematopoietic stem cell transplantation.2024
  4. 4Safety outcomes in adult patients with AML who achieved their first complete remission with GO prior to HSCT.2024
  5. 5Combination 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)2025