The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients

July 26, 2022 updated by: Shenzhen Second People's Hospital

The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in Patients With Chronic Myeloid Leukemia in Chronic Phase: an Randomized Controlled Trial.

The purpose of this study is to explore the efficacy and safety of switching to flumatinib versus dasatinib after imatinib-related low-grade adverse events in patients with chronic myeloid leukemia in chronic phase (CML-CP) in China. This is a post-marketing, interventional, double-arm, prospective, open-label, randomized controlled study in CML-CP patients in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given flumatinib or dasatinib under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

118

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518035
        • Recruiting
        • Shenzhen Second People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age ≥ 18 years;
  • Diagnosis of CML-CP with Ph+;
  • ECOG 0, 1, or 2;
  • Patients with imatinib-related Low-grade Adverse Events for more than 12 months and AE lasting for at least 2 months, or relapsed at least 3 times in the past 12 months;
  • Ability to provide written informed consent prior to any study related screening procedures being done

Exclusion Criteria:

  • Previously documented T315I mutation;
  • Previous treatment with any other tyrosine kinase inhibitor except for imatinib;
  • Prior accelerated phase or blast phase CML;
  • Loss of CHR or cytogenetic response

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Flumatinib
600mg QD orally form 1 to 12 months
Drug: Flumatinib
Flumatinib 600mg QD orally form 1 to 12 months
Placebo Comparator: Dasatinib
100mg QD orally form 1 to 12 months
Drug: Dasatinib
Dasatinib 100mg QD orally form 1 to 12 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change of (CTCAE grading scale) of imatinib related chronic low grade non hematologic Adverse Event after switch to treatment with flumatinib or dasatinib at 3 months.
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.
Time Frame: 12 months
12 months
Time to optimal imatinib-related adverse event improvement.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Second People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Anticipated)

April 30, 2023

Study Completion (Anticipated)

June 30, 2023

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 18, 2021

First Posted (Actual)

June 21, 2021

Study Record Updates

Last Update Posted (Actual)

July 27, 2022

Last Update Submitted That Met QC Criteria

July 26, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20210609

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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