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December 8, 2025Blood

Tagraxofusp and low-intensity chemotherapy for the treatment of CD123-positive relapsed or refractory Acute Myeloid Leukemia

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Authors

VCVivek CharuAEAsiri EdiriwickremaGMGabriel N. Mannis

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Overview

Phase 1b/2 trial shows safety and tolerability of Tagraxofusp with cladribine and low-dose cytarabine in relapsed AML, indicating potential for improved outcomes.

Key Points

  • This study aims to evaluate the safety and tolerability of Tagraxofusp combined with cladribine and low-dose cytarabine in patients with relapsed or refractory CD123-positive AML after prior treatment.
  • Single-center, open-label Phase 1b/2 trial
  • Enrolling up to 20 patients aged ≥18 years with relapsed AML after venetoclax/hypomethylating agent therapy
  • Cohorts treated with specified doses of CLAD, LDAC, and TAG, with dose escalation based on safety
  • Primary objective is to determine the recommended Phase 2 dose based on safety evaluations
  • Secondary objectives include assessing overall response rates and complete response
  • Evaluating outcomes based on mutational profiles and leukemia stem cell characteristics

Cite This Study

Charu et al. (2025) studied this question.

synapsesocial.com/papers/69362f714fa91c937236e17fhttps://doi.org/10.1182/blood-2025-8256
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Also Consider

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

  1. 1Tagraxofusp, azacitidine, and venetoclax (TAG-AZA-VEN) triplet therapy shows efficacy, tolerability, and transplant potential in patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN): Results of a phase 2 trial2025 · 4 citations
  2. 2Tagraxofusp, Azacitidine, and Venetoclax in Blastic Plasmacytoid Dendritic Cell Neoplasm2026 · 1 citations
  3. 3A phase II trial of tagraxofusp, hyper-CVAD, and venetoclax for patients with newly diagnosed or relapsed/refractory BPDCN.2026
  4. 4Cladribine (CLAD) + low-dose AraC (LDAC) + venetoclax (VEN) in patients with acute myeloid leukemia and high-risk myelodysplastic syndrome: Real-world analysis from a large community-based oncology practice.2026
  5. 5Prospective evaluation of venetoclax combined with CLAG regimen in relapsed/refractory acute myeloid leukemia: A multicenter, randomized controlled, open-lable, phase II Trial2025