Improving treatment outcomes in chronic myeloid leukaemia patients using imatinib and artesunate combination therapy: a randomized controlled clinical trial protocol (IMART-trial)
DOI:
https://doi.org/10.18203/2349-3259.ijct20253336Keywords:
Imatinib-artesunate, Combination therapy, Chronic myeloid leukaemia, Suboptimal response, Drug repurposingAbstract
Background: Chronic myeloid leukaemia (CML) is a haematological cancer accounting for 15% of newly diagnosed cancers in adults. Imatinib, a tyrosine kinase inhibitor (TKI), has transformed a once-fatal disease into a manageable condition. However, about one-third of patients develop resistance to the drug, increasing the disease burden and risk of progression, especially in low-and middle-income countries where newer TKIs are expensive and limited. Artesunate, an antimalarial drug, has been reported to exhibit anti-neoplastic effects alone or in synergy with other anti-neoplastic agents.
Methods: This randomised controlled trial will evaluate the clinical efficacy of the combination therapy of imatinib and artesunate in imatinib-naive patients and sub-optimal responder patients as defined by the European LeukemiaNet. Patients will be given imatinib at 400 mg daily, while the test groups will also receive artesunate (200 mg daily for 14 days monthly). Serial clinical assessments, laboratory investigations and pharmacokinetic analyses will be conducted at 1, 3, 6, 9, and 12 months into therapy. The treatment outcomes for each patient will be determined using the complete blood count and BCR::ABL1 quantification.
Conclusions: An imatinib-artesunate combination therapy could be a cost-effective solution to the development of imatinib resistance in newly diagnosed CML patients and possible alternative option in the management of sub-optimal response to imatinib.
Trial registration: Trial registration number is NCT07022743.
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