Comparing Flumatinib and Nilotinib for Newly Diagnosed Chronic Myeloid Leukemia

Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia(CML-CP) : A Multicenter, Open-lable, Real World Study

This study is testing whether flumatinib or nilotinib works better for people who have just been diagnosed with chronic myeloid leukemia.

Quick facts

• Study type: Observational
• Enrollment: 491 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The First Affiliated Hospital of Soochow University (Academic / other)
• Drugs / interventions: nilotinib, flumatinib, flumartinib, dasatinib, imatinib
• Locations: 1 site (Suzhou, Jiangsu)
• Trial ID: NCT04739826 on ClinicalTrials.gov

What this trial studies

This observational study aims to compare the efficacy of two second-generation tyrosine kinase inhibitors, flumatinib and nilotinib, in treating newly diagnosed patients with chronic phase chronic myeloid leukemia (CML-CP). The study will involve patients who have been diagnosed with CML within the last six months and have started treatment with either of the two medications. By analyzing real-world data from multiple centers, the study seeks to determine which treatment leads to better outcomes in terms of deep molecular response and the potential for treatment-free remission. The findings could help refine treatment guidelines for CML-CP patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with chronic phase chronic myeloid leukemia within the past six months.

Not a fit: Patients with specific genetic mutations related to nilotinib treatment or those currently participating in other therapeutic clinical trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could help identify the more effective treatment option for newly diagnosed CML-CP patients, potentially improving their long-term outcomes.

How similar studies have performed: While there have been successful studies comparing other second-generation TKIs, this specific direct comparison between flumatinib and nilotinib in newly diagnosed CML-CP patients is novel.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients ≥18 years of age;
2. CML-CP patients diagnosed with CML within half a year；Patients who have been using second-generation TKI nilotinib or flumatinib for first-line treatment in clinical practice, but the history of continuous treatment does not exceed 3 months；3.patients are allowed to receive hydroxyurea treatment before first-line treatment with nilotinib or flumartinib; patients treated with interferon for no more than 3 months and other TKIs for no more than 2 weeks;

4.Patients who must sign informed consent before screening

Exclusion Criteria:

1. T315I mutation ; Y253F/H, E255K/V, F359C/V/I mutations in the nilotinib group;
2. Entry into another therapeutic clinical trial;
3. Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
4. History of neurological or psychiatric disorders, including epilepsy or dementia;
5. Major surgery within 4 weeks prior to Day 1 of study;
6. Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
7. Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
8. ECOG≥3;
9. Patients who are unable to compliance with study or follow-up procedures;

Where this trial is running

Suzhou, Jiangsu

• The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology — Suzhou, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Suning Chen

Conditions CML, Chronic Phase; TKI