Evaluating Flumatinib for Chronic Myeloid Leukemia Patients with Suboptimal Response to Imatinib or Dasatinib

Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning or Failure) to Imatinib or Dasatinib: A Prospective, Multicenter, Pragmatic Clinical Trial

This study is testing if a new drug called Flumatinib can help people with chronic myeloid leukemia who aren't getting good results from their current treatments.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wuhan Union Hospital, China (Academic / other)
• Drugs / interventions: imatinib, dasatinib, nilotinib, Flumatinib
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT04681820 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Flumatinib in patients with chronic phase chronic myeloid leukemia (CML-CP) who have not achieved optimal responses to standard treatments like Imatinib or Dasatinib. It focuses on patients with specific mutations that may affect their response to treatment. The study aims to provide insights into alternative treatment options for those experiencing drug resistance or disease progression. Participants will be monitored for their response to Flumatinib and any associated safety concerns.

Who should consider this trial

Good fit: Ideal candidates include adult patients with chronic phase CML who have not responded optimally to Imatinib or Dasatinib.

Not a fit: Patients with acute phase CML or those who have not been treated with Imatinib or Dasatinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for CML-CP patients who are resistant to current therapies.

How similar studies have performed: Other studies have shown success with similar approaches in targeting specific mutations in CML, indicating potential for this treatment strategy.

Eligibility criteria

Inclusion Criteria:

1. Male or female patients ≥18 years of age;
2. CML-CP patients when enrolled

   Definition of diagnosis:

   Bone marrow cytogenetic confirmation of Philadelphia chromosome of t (9;22) translocations and/or the presence of P210 BCR-ABL1 transcripts via molecular assessment;

   Documented chronic phase CML will meet all the criteria defined as:

   \< 15% blasts in peripheral blood and bone marrow \< 30% blasts plus promyelocytes in peripheral blood and bone marrow \< 20% basophils in the peripheral blood

   ≥ 100 x 109/L (≥ 100,000/mm3) platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
3. CML-CP patients without optimal response(warning or failure) when treated with imatinib or dasatinib.
4. Female patients of childbearing potential must have a negative serum pregnancy test;
5. Ability to provide written informed consent prior to any study related screening procedures being performed.

Exclusion Criteria:

1. Treatment with other tyrosine kinase inhibitor(s) except imatinib and dasatinib prior to study entry;
2. With any mutations as follows :T315I、Y253F/H、E255K/V、F359C/V/I (if there are any other mutations,at physicians' discretion );
3. Entry into another therapeutic clinical trial;
4. Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
5. History of neurological or psychiatric disorders, including epilepsy or dementia;
6. Major surgery within 4 weeks prior to Day 1 of study;
7. Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
8. Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
9. ECOG≥3;
10. Patients who are unable to compliance with study or follow-up procedures;
11. Allergic to any of the components in this trial;
12. Not appropriate to attend this trial judged by the investigator.

Where this trial is running

Wuhan, Hubei

• Weiming Li — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Weiming Li

Conditions CML-CP; Mutation; Suboptimal Response or Failure in TKI