ArticleCancer chemotherapy and pharmacology2025
Selection of isatuximab dosing regimen in pediatric patients with leukemia using population pharmacokinetics.
Article in Cancer chemotherapy and pharmacology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 1 paper.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 2, Safety and Efficacy Study of Isatuximab, an Anti-CD38 Monoclonal Antibody, Administered by Intravenous (IV) Infusion in Patients With Relapsed or Refractory T-acute Lymphoblastic Leukemia (T-ALL) or T-lymphoblastic Lymphoma (T-LBL)
Open-label, Single-arm Trial to Evaluate Antitumor Activity, Safety, and Pharmacokinetics of Isatuximab Used in Combination With Chemotherapy in Pediatric Patients From 28 Days to Less Than 18 Years of Age With Relapsed/Refractory B or T Acute Lymphoblastic Leukemia or Acute Myeloid Leukemia in First or Second Relapse
Who cites it
1 citing paper in PubMed.
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Authors and funding
6 authors.
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No grant is acknowledged in the PubMed record.
Abstract
purposeIsatuximab, an immunoglobulin G monoclonal antibody that targets a specific CD38 epitope, is approved in combination with dexamethasone plus either pomalidomide or carfilzomib for treatment of adults with relapsed or refractory (R/R) multiple myeloma. Isatuximab demonstrated significant anti-leukemic activity in preclinical models. In the phase 2 ISAKIDS study (NCT03860844), isatuximab was tested as combination therapy for pediatric patients with R/R acute lymphoblastic leukemia and acute myeloid leukemia. Here, we use population pharmacokinetics (PopPK) to select the appropriate isatuximab dose for infants aged 1-24 months in ISAKIDS.
methodsAn initial PK modeling and simulation strategy was applied to the first 18 tested patients to confirm the isatuximab 20-mg/kg dose administered to patients aged 24 months or older and to explore the dose needed for the youngest patients. The PK of isatuximab in children was characterized by pooling data from ISAKIDS with adult data from the phase 2 ISLAY study (NCT02999633).
resultsThe PopPK model predicted a slight drug underexposure (median decrease of about 30%) in pediatric patients aged 10-24 months (9-12 kg) compared with reference adults (51-100 kg), which did not require a dose adjustment, as no isatuximab exposure versus efficacy relationships were observed in these clinical settings.
conclusionThe modeling and simulation strategies in this study support the previous selection of a 20-mg/kg dose for all age groups and enabled both de-risking of dose selection and the ability to pursue additional pediatric investigation of isatuximab in the youngest age group of patients with acute leukemias.
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Registered trials
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