Evaluating Flumatinib for Newly Diagnosed Chronic Myeloid Leukemia

A Double-blind , Randomized, Multicenter, Phase 4 Study to Evaluate Efficacy and Safety of Oral Flumatinib 400mg Versus 600mg in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase.

This study is testing two different doses of flumatinib to see which one helps adults with newly diagnosed chronic myeloid leukemia feel better and respond to treatment.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 74 Years
• Sex: All
• Sponsor: Jiangsu Hansoh Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: flumatinib, fluamtinib
• Locations: 1 site (Harbin, Hei Longjiang)
• Trial ID: NCT05353205 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy and safety of two different doses of flumatinib (400mg and 600mg once daily) in adult patients with newly diagnosed chronic myeloid leukemia in chronic phase. It is a double-blind, randomized, multi-center trial where eligible participants are assigned to one of the two dosing groups in a 1:1 ratio. The primary goal is to assess the rate of early molecular response at three months, with additional evaluations of hematologic and cytogenetic responses throughout the study. Patients will be monitored for treatment failure, disease progression, or any adverse effects leading to discontinuation.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase.

Not a fit: Patients with atypical CML, additional chromosomal abnormalities, or prior treatment with tyrosine kinase inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective and safer dosing regimen for patients with chronic myeloid leukemia.

How similar studies have performed: Other studies have shown promising results with similar approaches in optimizing treatment for chronic myeloid leukemia.

Eligibility criteria

Inclusion Criteria:

1. Signed informed consent form.
2. Men or women aged more than or equal to (≥) 18 years, and less than (\<) 75 years.
3. ECOG performance status of 0-2.
4. Patients with philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP) within 6 months of diagnosis.
5. Adequate organ function.
6. Men or women should be using adequate contraceptive measures throughout the study; Females should not be breastfeeding at the time of screening, during the study and until 6 months after completion of the study.
7. Females must have evidence of non-childbearing potential.

Exclusion Criteria:

1. Known atypical CML or presence of additional chromosomal abnormalities.
2. Known presence of the T315I mutation.
3. Treatment with tyrosine kinase inhibitor(s) prior to randomization.
4. Any treatment with anti-CML activity for longer than 2 weeks(exception of hydroxyurea or anagrelide) or hematopoietic stem cell transplantation prior to randomization .
5. Prior treatment with splenectomy.
6. Impaired cardiac function including any one of the following:

   1. Resting corrected QT interval (QTc) \> 470 ms obtained from electrocardiogram (ECG), using the screening clinic's ECG machine and Fridericia's formula for QT interval correction (QTcF).
   2. Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG.
   3. Any factors that increase the risk of QTc prolongation or risk of arrhythmic events,
   4. Left ventricular ejection fraction (LVEF) ≤ 50%.
   5. During screening period, ECG examination showed average heart rate \<50 beats per minute.
   6. Myocardial infarction occurred within 12 months of randomization;
   7. Congestive heart failure occurred within 6 months of randomization;
   8. Uncontrollable angina.
7. Stroke or transient ischemic attack within 6 months of randomization.
8. Any severe or uncontrolled systemic diseases (i.e. uncontrolled hypertension or diabetes).
9. Clinically severe gastrointestinal dysfunction that may affect drug intake, transport or absorption.
10. The presence of active infectious diseases has been known prior to randomization
11. History of significant congenital or acquired bleeding disorders unrelated to CML
12. Inadequate other organ function.
13. History of other malignancies.
14. History of hypersensitivity to any active or inactive ingredient of flumatinib.
15. Patients who are currently receiving treatment with any medications that have the potential to prolong the QT interval and the treatment cannot be either discontinued.
16. Major surgery within 4 weeks of randomization.
17. Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 within 4 weeks of randomization.
18. Any disease or condition that, in the opinion of the investigator, would compromise the safety of the patient or interfere with study assessments.
19. Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.

Where this trial is running

Harbin, Hei Longjiang

• Institute of Hematology and Oncology, Harbin The First Hospital — Harbin, Hei Longjiang, China (Recruiting)

Study contacts

• Principal investigator: Jun Ma — Institute of Hematology and Oncology, Harbin The First Hospital
• Study coordinator: Jun Ma

Conditions CML, Chronic Phase; Flumatinib; BCR-ABL TKI; Dose-optimization; Double-blind; Phase 4