ArticleEClinicalMedicine2025
Mitoxantrone in combination with clofarabine (MITCL) in children, adolescents and young adults with relapsed/refractory acute leukaemia: final results of a phase I/II trial.
Article in EClinicalMedicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Authors and funding
11 authors.
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Abstract
Background: Children with relapsed/refractory acute leukaemias have lower response rates to reinduction and decreased overall survival. Mitoxantrone and clofarabine both have proven efficacy in acute leukaemia. We present our final results utilising this novel reinduction platform as a bridge to haematopoietic stem cell transplantation (HSCT) in children with high-risk pediatric leukaemias. Methods: From 2013 to 2021, patients 0-30.99 yr old with acute lymphoblastic leukaemia (ALL) or acute myelogenous leukaemia (AML) with relapse/refractory disease were given 1 to 3 cycles of clofarabine (escalating doses 20, 30, 35 and 40 mg/m Findings: Forty patients enrolled (18 phase I, 22 phase II) with median age 13 yrs (8 months-23 yrs). Demographics: 22 ALL (10 = induction failure [IF]/minimal residual disease [MRD], 9 = Relapse 1, 3 = Relapse 2), 17 AML (9 = IF/MRD, 6 = Relapse 1, 2 = Relapse 2). During phase I, there were 2 dose-limiting toxicities (DLTs) at dose level 4 requiring de-escalation to dose level 3. The phase I MTD was established at 35 mg/m Interpretation: The MTD of clofarabine in combination with mitoxantrone reinduction therapy was 35 mg/m Funding: Pediatric Cancer Research Foundation, Pediatric Cancer Foundation, Children's Cancer Fund, St. Baldrick's Foundation, Carolinas Healthcare, and NCCF subcontract #16252.
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