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

Primary Purpose

Flumatinib, Chronic Myeloid Leukemia, Chronic Phase, Imatinib

Status

Recruiting

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Flumatinib

About this trial

This is an interventional treatment trial for Flumatinib focused on measuring Flumatinib, CML-CP with Ph+

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 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.

Exclusion Criteria:

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.

Sites / Locations

The Second People's Hospital of ShenzhenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Flumatinib

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.

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

Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.

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

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

Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.

Full Information

NCT ID

NCT04677439

First Posted

December 16, 2020

Last Updated

March 15, 2022

Sponsor

Shenzhen Second People's Hospital

Collaborators

Hainan General Hospital, Sanya Central Hospital, First Affiliated Hospital of Shantou University Medical Collegeity, Peking University Shenzhen Hospital, Dongguan People's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04677439

Brief Title

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

Official Title

Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2021 (Actual)

Primary Completion Date

May 30, 2023 (Anticipated)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shenzhen Second People's Hospital

Collaborators

Hainan General Hospital, Sanya Central Hospital, First Affiliated Hospital of Shantou University Medical Collegeity, Peking University Shenzhen Hospital, Dongguan People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

A multicenter, single-arm, prospective, open-label study to detect the efficacy and safety of flumatinib by measuring rates of major molecular response (MMR) at 12 months in CML-CP patients with Ph+ in China. Approximately 200 Patients will be recruited consecutively from the study sites during the enrollment period and will be given flumatinib 600 mg QD. The duration of patient participation will be 24 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Flumatinib, Chronic Myeloid Leukemia, Chronic Phase, Imatinib

Keywords

Flumatinib, CML-CP with Ph+

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Flumatinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Flumatinib

Intervention Description

600 mg of Flumatinib orally daily for 24 months

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

12 months

Secondary Outcome Measure Information:

Title

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

Description

Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.

Time Frame

3, 6, 9, 12 months.

Title

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

Description

Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.

Time Frame

3, 6, 9, 12 months.

Title

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

Time Frame

3, 6, 9 months

Title

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

Description

Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Du, Phd

Phone

075583366388

duxingz@medmail.com.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xin Du, Phd

Organizational Affiliation

Shenzhen Second People's Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Second People's Hospital of Shenzhen

City

Shenzhen

State/Province

Guangdong

ZIP/Postal Code

518035

Country

China

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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