Clinical trial NCT04739826: Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: CML, Chronic Phase; TKI
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib

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.


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;

Primary outcomes:
measure: Major molecular response rate at 12 months
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
state: Jiangsu
Study officials:
References: