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

NCT07022743 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-09-05

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Myeloid Leukemia (CML)

Interventions

DRUG

Imatinib

Imatinib is a first-line tyrosine kinase inhibitor which is used in the management of chronic myeloid leukaemia. It will be used by all the patients in the 3 arms of the study (Groups A, B and C)

DRUG

Artesunate

Artesunate has been established to reverse resistance to some chemotherapeutic agents. patients in 2 arms of the study (Groups B and C) will be given artesunate at 4mg/kg (not exceeding 200mg daily) in combination with imatinib

Sponsors & Collaborators

  • Obafemi Awolowo University

    lead OTHER

Principal Investigators

  • Prof. R. A. Bolarinwa · Obafemi Awolowo University, Ile-Ife

  • Dr. B. A. Adeagbo · Obafemi Awolowo University, Ile-Ife

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2026-07-31
Completion
2026-12-31

Countries

  • Nigeria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07022743 on ClinicalTrials.gov