Improving Treatment Outcomes in Chronic Myeloid Leukaemia Patients Using Imatinib and Artesunate Combination Therapy

StatusActive, Not Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 10 months later Jul 2026 → Jun 2027
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Record History

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  1. Notable Primary completion pushed from Jul 2026 to Jun 2027 Show 4 more changesShow less
    • Study completion pushed from Dec 2026 to Jun 2027
    • Eligibility criteria expanded, about 6 words
    • Study description expanded, about 6 words
    • Publications: details revised at 8 of 8 entries
  2. Notable Start date: May 15, 2025 to Jul 1, 2025
    • Primary completion date: May 2026 to Jul 2026
    v3
  3. Minor Interventions: Artesunate (Drug), Imatinib (Glivec) (Drug) to Artesunate (Drug), Imatinib (Drug)v2 Show 4 more changesShow less
    • Secondary endpoints: details revised at 3 of 3 entries
    • Study description shortened, about 408 words
    • Publications: 3 to 8
    • Eligibility criteria shortened, about 4 words
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic myeloid leukaemia (CML) is a blood cancer with an annual worldwide incidence of 1/100,000 population. Imatinib is used for the treatment of CML and has significantly improved the management of the disease. However, the incidence of treatment failure due to imatinib resistance has become a considerable burden (Sherbenou et al., 2007). Artesunate, an antimalarial drug, is reported to have anti-neoplastic effect either singly or in synergy with already established anti-neoplastic agents (Krishna et al., 2015). The aim of the study is to evaluate the clinical effectiveness of an Imatinib-artesunate combination compared to imatinib alone and its possibility as an alternative option in the management of sub-optimal response in CML patients especially in low- and middle- income country like Nigeria where second line tyrosine kinase inhibitor may be out of reach. The specific objectives are to: 1. Assess the safety of artesunate use beyond its traditional antimalarial dosing period in CML patients. 2. Compare treatment outcomes between patients on imatinib alone and patients on imatinib plus artesunate at 3, 6 and 12-months of follow-up. 3. Determine the effect of imatinib and artesunate combination on the achievement of major molecular remission in CML patients with sub-optimal response to imatinib. 4. Determine the effect of artesunate on imatinib pharmacokinetics following co-administration of the two drugs. The main questions it aims to answer is: * Does the use of artesunate in combination with imatinib in newly diagnosed CML patient give a better therapeutic outcome than using imatinib alone? * Does combining artesunate with imatinib in CML patients with sub-optimal response to imatinib improve patients' response to imatinib? * Does combining artesunate with imatinib in CML patients affect the pharmacokinetic parameter of imatinib? * Is it safe to take artesunate at 4mg/day (not exceeding 200mg/day) for a 14day cycle in CML patients as demonstrated in other forms of cancer? Participants will be assigned to one of the groups of the study and continue imatinib medication irrespective of the group assigned and come to clinic once a month for follow-up. Clinic visits will be immediately after a cycle of artesunate for groups B and C.
Trial Details
NCT Number NCT07022743
Lead Sponsor Obafemi Awolowo University
Conditions
(from sponsor)
Chronic Myeloid Leukemia (CML)
Related terms Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov