Flumatinib in CML-CP Patients With Ph+ Post Imatinib Failure

NCT04677439 | Unknown Phase 4

• 1 other identifier: Flumatinib20201216
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy and safety of flumatinib in chronic phase of chronic myeloid leukemia (CML-CP) patients With Ph+ post imatinib failure.

Conditions

Flumatinib; Chronic Myeloid Leukemia, Chronic Phase; Imatinib

Keywords

Flumatinib, CML-CP with Ph+

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test.

  Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.

  12 months

Secondary Outcomes (4)

• Proportion of patients with MR 4.0 at 3, 6, 9, 12 months.

  3, 6, 9, 12 months.

• Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.

  3, 6, 9, 12 months.

• Proportion of patients with MMR at 3, 6, 9 months.

  3, 6, 9 months

• Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib.

  24 months

Study Arms (1)

Flumatinib

EXPERIMENTAL

Drug: Flumatinib

Interventions

Flumatinib DRUG

600 mg of Flumatinib orally daily for 24 months

Flumatinib

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 performance of 0-2.
• Adequate end organ function defined as the following: total bilirubin \<1.5x ULN, SGPT \<2.5x ULN, creatinine \<1.5x ULN.
• Treatment failure after imatinib at 3 or 6 months with BCR-ABL \>10%.
• Patients must sign an informed consent form (ICF) indicating they are aware of the investigational nature of this study, in keeping with the policies of the hospital.

You may not qualify if:

• Previously documented T315I mutation.
• History of TKI treatments except of imatinib.
• History of undergone major surgery within 4 weeks.
• Patients unwilling or unable to comply with the protocol.
• Pregnant or breast-feeding patients.
• patients with other malignant tumor.

Sponsors & Collaborators

• Shenzhen Second People's Hospital: lead
• Hainan General Hospital: collaborator
• Sanya Central Hospital: collaborator
• First Affiliated Hospital of Shantou University Medical College: collaborator
• Peking University Shenzhen Hospital: collaborator
• Dongguan People's Hospital: collaborator

Study Sites (1)

The Second People's Hospital of Shenzhen

Shenzhen, Guangdong, 518035, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Chronic-Phase

Interventions

flumatinib

Condition Hierarchy (Ancestors)

Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Myeloproliferative Disorders; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xin Du, Phd

  Shenzhen Second People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Du, Phd

CONTACT

075583366388; duxingz@medmail.com.cn

Study Design

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

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 21, 2020
• Study Start: January 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: December 30, 2023
• Last Updated: March 16, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)