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RecruitingNCT04739826Updated Nov 3, 2023

Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

An observational study in CML, Chronic Phase; TKI, sponsored by The First Affiliated Hospital of Soochow University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-11-03.

Sponsored by The First Affiliated Hospital of Soochow University · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Sep 2020; still recruiting 6 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
491
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

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In context

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

964 studies on the registry are indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive; 109 are open to participants now.

This study's planned enrollment of 491 is above the median of 141 across 149 observational studies indexed under Leukemia, Myelogenous, Chronic, BCR-ABL Positive.

Browse Leukemia, Myelogenous, Chronic, BCR-ABL Positive studies →

Lead sponsor

The First Affiliated Hospital of Soochow University is the lead sponsor of 252 studies on the registry; 148 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Newly diagnosed chronic-phase CML patients (CMP-CP) treated with flumatinib or Nilotinib

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

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;
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
491 participants (estimated)
Patient registry
No

Groups and cohorts

  • flumatinib

    flumatinib 600mg QD, fasting administration

    Drug: Flumatinib Mesylate · Drug: Nilotinib Pill

  • nilotinib

    nilotinib 300mg BID, fasting administration

    Drug: Flumatinib Mesylate · Drug: Nilotinib Pill

Interventions

  • DrugFlumatinib Mesylate

    Flumatinib mesylate tablets 600mg qd

  • DrugNilotinib Pill

    Nilotinib Capsules 300mg bid

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What researchers measure

Primary outcomes

  1. Major molecular response rate at 12 months

    Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale

    Time frame: 12 months

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Study locations

1 of 1 sites recruiting
  • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
    Suzhou, Jiangsu 215000, China
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04739826
Lead sponsor
The First Affiliated Hospital of Soochow University
Responsible party
Sponsor
First posted
Feb 5, 2021
Start date
Sep 25, 2020
Primary completion
Jan 2025 (estimated)
Completion
Dec 2025 (estimated)
Last update
Nov 3, 2023

Study contacts

Suning Chen
Contact
chensuning@sina.com
13814881746

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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