Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

NCT ID: NCT04739826

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 491 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-09-25
• Study Completion Date: 2025-12-31

Brief Summary

The ultimate goal of CML treatment is to improve survival, including overall survival (OS), progression-free survival (PFS), event-free survival (EFS), and treatment-free remission (TFR). TFR is a new therapeutic goal for chronic myeloid leukemia in chronic phase (CML-CP). In ENESTnd and DASISION trials, both nilotinib and dasatinib achieved DMR more effectively than imatinib. In the guidelines for diagnosis and treatment of chronic myeloid leukemia in China (2020 edition), flumatinib has been recommended as an appropriate first-line treatment for newly diagnosed chronic phase chronic myeloid leukemia (CML-CP) patients. There is no doubt that the second-generation TKIs show great advantages in deep molecular response, which further increases the possibility of achieving treatment-free remission. However, there is no direct comparative study to determine which TKI is better for de novo CML-CP. Thus, we conducted a multi-center, open-lable and real world study to compare the efficacy and safety between flumatinib and nilotinib.

Conditions

CML, Chronic Phase; TKI

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

flumatinib

flumatinib 600mg QD, fasting administration

Flumatinib Mesylate

Intervention Type: DRUG

Flumatinib mesylate tablets 600mg qd

Nilotinib Pill

Intervention Type: DRUG

Nilotinib Capsules 300mg bid

nilotinib

nilotinib 300mg BID, fasting administration

Flumatinib Mesylate

Intervention Type: DRUG

Flumatinib mesylate tablets 600mg qd

Nilotinib Pill

Intervention Type: DRUG

Nilotinib Capsules 300mg bid

Interventions

Flumatinib Mesylate

Flumatinib mesylate tablets 600mg qd

Intervention Type: DRUG

Nilotinib Pill

Nilotinib Capsules 300mg bid

Intervention Type: DRUG

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;

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Suning Chen

Role: CONTACT

chensuning@sina.com

13814881746

Facility Contacts

Suning Chen

Role: primary

chensuning@sina.com

13814881746

Other Identifiers

HS-2020-07SZ

Identifier Type: -

Identifier Source: org_study_id