search
Back to results

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

Primary Purpose

Chronic Myeloid Leukemia in Chronic Phase

Status
Recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Flumatinib
Dasatinib
Sponsored by
Shenzhen Second People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Myeloid Leukemia in Chronic Phase focused on measuring Chronic Myeloid Leukemia in Chronic Phase, Imatinib, Flumatinib, Dasatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Shenzhen Second People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Flumatinib

Dasatinib

Arm Description

600mg QD orally form 1 to 12 months

100mg QD orally form 1 to 12 months

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 9, 2021
Last Updated
July 26, 2022
Sponsor
Shenzhen Second People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04933526
Brief Title
The Efficacy and Safety of Switching to Flumatinib Versus Dasatinib After Imatinib-related Low-grade Adverse Events in CML-CP Patients
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Myeloid Leukemia in Chronic Phase
Keywords
Chronic Myeloid Leukemia in Chronic Phase, Imatinib, Flumatinib, Dasatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Flumatinib
Arm Type
Active Comparator
Arm Description
600mg QD orally form 1 to 12 months
Arm Title
Dasatinib
Arm Type
Placebo Comparator
Arm Description
100mg QD orally form 1 to 12 months
Intervention Type
Drug
Intervention Name(s)
Flumatinib
Intervention Description
Flumatinib 600mg QD orally form 1 to 12 months
Intervention Type
Drug
Intervention Name(s)
Dasatinib
Intervention Description
Dasatinib 100mg QD orally form 1 to 12 months
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.
Time Frame
12 months
Title
Time to optimal imatinib-related adverse event improvement.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Du
Phone
075583366388
Email
duxingz@medmail.com.cn
Facility Information:
Facility Name
Shenzhen Second People's Hospital
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Du, MD
Phone
075583366388
Ext
8196
Email
duxingz@medmail.com.cn

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs