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Immunotherapy for acute leukemia: An updated SITC clinical practice guideline

By Megan Moore

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Oct 28, 2026

Learning objective: After reading this article, learners will be able to cite a new clinical development in acute myeloid leukemia.


An updated Society for Immunotherapy of Cancer (SITC) clinical practice guideline (version 2.0) on immunotherapy for the treatment of acute leukemia was published in Journal for ImmunoTherapy of Cancer by Shah et al. The guideline was developed by a multidisciplinary expert panel and includes evidence-based and consensus-based recommendations across diagnostic assessment, immunotherapy selection and treatment sequencing, response monitoring, toxicity management, and patient education and quality-of-life support.

Key data: Among adult patients with newly diagnosed (ND) acute myeloid leukemia (AML), gemtuzumab ozogamicin is strongly recommended for core binding factor AML (CBF-AML), may be considered for intermediate-risk AML, and is not recommended for adverse-risk AML. For pediatric patients with ND AML, gemtuzumab ozogamicin is recommended alongside induction therapy across all risk groups and may also be considered in combination with multiagent chemotherapy and relevant targeted inhibitors. Gemtuzumab ozogamicin is also recommended for adults and children aged ≥2 years with relapsed/refractory (R/R) CD33-positive AML. Referral to a specialist center for allogeneic hematopoietic stem cell transplantation (allo-HSCT) consideration is recommended for adults with AML, although transplantation is generally not recommended in first complete remission for favorable-risk disease; measurable residual disease (MRD) status should inform decisions. Referrals are also recommended for pediatric patients with high-risk features or end-of-induction MRD positivity without favorable-risk genetic alterations, and for patients with R/R AML.

Key learning: This updated guideline provides a comprehensive framework to support hematologists and oncologists in treating AML, highlighting immunotherapy indications and risk-adapted treatment approaches.

 

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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.