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

Sponsor
Shenzhen Second People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04933526
Collaborator
(none)
118
1
2
24
4.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
118 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
Jun 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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. [3 months]

Secondary Outcome Measures

  1. Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy. [12 months]

  2. Time to optimal imatinib-related adverse event improvement. [12 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shenzhen Second People's Hospital Shenzhen Guangdong China 518035

Sponsors and Collaborators

  • Shenzhen Second People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier:
NCT04933526
Other Study ID Numbers:
  • 20210609
First Posted:
Jun 21, 2021
Last Update Posted:
Jul 27, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shenzhen Second People's Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 27, 2022