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

NCT04933526 | Unknown Phase 4

• 1 other identifier: 20210609
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Myeloid Leukemia in Chronic Phase

Keywords

Chronic Myeloid Leukemia in Chronic Phase; Imatinib; Flumatinib; Dasatinib

Outcome Measures

Primary Outcomes (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 Outcomes (2)

• Rate of a Major Molecular Response (MMR) after the switch to flumatinib or dasatinibin the therapy.

  12 months

• Time to optimal imatinib-related adverse event improvement.

  12 months

Study Arms (2)

Flumatinib

ACTIVE COMPARATOR

600mg QD orally form 1 to 12 months

Drug: Flumatinib

Dasatinib

PLACEBO COMPARATOR

100mg QD orally form 1 to 12 months

Drug: Dasatinib

Interventions

Flumatinib DRUG

Flumatinib 600mg QD orally form 1 to 12 months

Flumatinib

Dasatinib DRUG

Dasatinib 100mg QD orally form 1 to 12 months

Dasatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead

Study Sites (1)

Shenzhen Second People's Hospital

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Interventions

flumatinib; Dasatinib

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Central Study Contacts

Xin Du

CONTACT

075583366388; duxingz@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 21, 2021
• Study Start: July 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: June 30, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-06

Locations

CN (1)