Flumatinib Versus Nilotinib for Newly Diagnosed Chronic Phase Chronic Myeloid Leukemia

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

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.

Study Overview

• Status: Recruiting
• Conditions: CML, Chronic Phase; TKI
• Intervention / Treatment: Drug: Flumatinib Mesylate; Drug: Nilotinib Pill

• Study Type: Observational
• Enrollment (Estimated): 491

Contacts and Locations

• Study Contact: Name: Suning Chen; Phone Number: 13814881746; Email: chensuning@sina.com

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • Recruiting
      • The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology
      • Contact: Suning Chen; Phone Number: 13814881746; Email: chensuning@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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;

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
flumatinib; flumatinib 600mg QD, fasting administration	Drug: Flumatinib Mesylate; Flumatinib mesylate tablets 600mg qd; Drug: Nilotinib Pill; Nilotinib Capsules 300mg bid
nilotinib; nilotinib 300mg BID, fasting administration	Drug: Flumatinib Mesylate; Flumatinib mesylate tablets 600mg qd; Drug: Nilotinib Pill; Nilotinib Capsules 300mg bid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major molecular response rate at 12 months	Major molecular response is defined as ≤ 0.1% BCR-ABL/ABL% by international scale	12 months

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2020
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): November 3, 2023
• Last Update Submitted That Met QC Criteria: November 1, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Histologic Type; Neoplasms; Disease Attributes; Bone Marrow Diseases; Hematologic Diseases; Myeloproliferative Disorders; Leukemia; Leukemia, Myeloid; Chronic Disease; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Chronic-Phase; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Flumatinib
• Other Study ID Numbers: HS-2020-07SZ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No