Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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;

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04739826
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	The First Affiliated Hospital of Soochow University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	CML, Chronic Phase; TKI

Arms & Interventions

Arms

: flumatinib

flumatinib 600mg QD, fasting administration

: nilotinib

nilotinib 300mg BID, fasting administration

Interventions

Drug: - Flumatinib Mesylate

Flumatinib mesylate tablets 600mg qd

Drug: - Nilotinib Pill

Nilotinib Capsules 300mg bid

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Suzhou, Jiangsu, China

Status

Recruiting

Address

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

Suzhou, Jiangsu, 215000

Site Contact

Suning Chen

[email protected]

13814881746

Site by: Kaleidoscopic

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