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December 8, 2025Blood

First-in-human phase I trial combining radiopharmaceutical therapy (RPT) using a 90y-anti-CD25 monoclonal antibody (Mab) with total marrow and lymphoid irradiation (TMLI) in relapsed or refractory (R/R) acute leukemia

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Authors

JWJeffrey WongMMMonzr M. Al MalkiVAVikram Adhikarla

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Overview

Phase I trial indicates 90Y-anti-CD25 Mab plus TMLI shows promise in older patients with R/R leukemia, highlighting safety and efficacy.

Key Points

  • This phase I trial aims to assess the safety and feasibility of combining 90Y-anti-CD25 Mab with TMLI in patients with relapsed or refractory acute leukemia.
  • Phase I trial utilized a 3+3 design to find maximum tolerated dose of 90Y-anti-CD25 Mab combined with TMLI, flu, and melphalan.
  • Patients over 60 or with significant comorbidities were included, receiving various dosages of the radiopharmaceutical therapy.
  • Dosimetry and pharmacokinetics were assessed via serial nuclear scans and modeling.
  • Seven patients were treated, with successful doses administered without dose-limiting toxicities observed.
  • All patients achieved complete remission after treatment, with median recovery metrics reported.
  • Observed complications included drug-related toxicities and acute and chronic graft-versus-host disease.

Cite This Study

Wong et al. (2025) studied this question.

synapsesocial.com/papers/69362f7d4fa91c937236e4bbhttps://doi.org/10.1182/blood-2025-508
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Also Consider

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

  1. 1Total marrow and lymphoid irradiation (TMLI) with fludarabine-melphalan (FM) conditioning for matched donor hematopoietic cell transplant (HCT) in older patients with Relapsed/Refractory (R/R) disease2025
  2. 2Total marrow and lymphoid irradiation (2000 cGy) together with cyclophosphamide and etoposide prior to allogeneic hematopoietic cell transplantation is an effective regimen for Relapsed/Refractory leukemia, with low non-relapse mortality2025
  3. 3Safety of myeloablative total marrow and lymphoid irradiation versus chemotherapy-based conditioning in adults with high-risk acute lymphoblastic leukemia in a limited resources setting2025
  4. 4Safety and feasibility of outpatient myeloablative total marrow and lymphoid Irradiation–based allogeneic transplantation in adults with high-risk acute lymphoblastic leukemia2025
  5. 5Yttrium-90 Anti-CD25-BEAM-Conditioning for Autologous Hematopoietic Cell Transplantation in Peripheral T Cell Lymphoma2024 · 2 citations