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

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ClinicalTrials.gov Identifier: NCT04677439
Recruitment Status : Recruiting
First Posted : December 21, 2020
Last Update Posted : January 20, 2021
Sponsor:
Collaborators:
Hainan General Hospital
Sanya Central Hospital
First Affiliated Hospital of Shantou University Medical Collegeity
Peking University Shenzhen Hospital
Dongguan People's Hospital
Information provided by (Responsible Party):
Shenzhen Second People's Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Flumatinib Chronic Myeloid Leukemia, Chronic Phase Imatinib Drug: Flumatinib Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and the Safety of Flumatinib in Treatment of CML-CP Patients With Ph+ Post Imatinib Failure
Actual Study Start Date : January 1, 2021
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : December 30, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Flumatinib Drug: Flumatinib
600 mg of Flumatinib orally daily for 24 months


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients who achieve and maintain MMR at 12 months using RQ-PCR test. [ Time Frame: 12 months ]
    Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.


Secondary Outcome Measures :
  1. Proportion of patients with MR 4.0 at 3, 6, 9, 12 months. [ Time Frame: 3, 6, 9, 12 months. ]
    Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.

  2. Proportion of patients with MR 4.5 at 3, 6, 9, 12 months. [ Time Frame: 3, 6, 9, 12 months. ]
    Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.

  3. Proportion of patients with MMR at 3, 6, 9 months. [ Time Frame: 3, 6, 9 months ]
  4. Incidence of adverse events (AEs) and serious adverse events (SAEs) to Flumatinib. [ Time Frame: 24 months ]
    Evaluation of adverse events (AEs), serious AEs (SAEs), and clinically relevant changes in laboratory tests according to laboratory reference ranges.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04677439


Contacts
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Contact: Xin Du, Phd 075583366388 duxingz@medmail.com.cn

Locations
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China, Guangdong
The Second People's Hospital of Shenzhen Recruiting
Shenzhen, Guangdong, China, 518035
Sponsors and Collaborators
Shenzhen Second People's Hospital
Hainan General Hospital
Sanya Central Hospital
First Affiliated Hospital of Shantou University Medical Collegeity
Peking University Shenzhen Hospital
Dongguan People's Hospital
Investigators
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Principal Investigator: Xin Du, Phd Shenzhen Second People's Hospital
More Information
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Responsible Party: Shenzhen Second People's Hospital
ClinicalTrials.gov Identifier: NCT04677439    
Other Study ID Numbers: Flumatinib20201216
First Posted: December 21, 2020    Key Record Dates
Last Update Posted: January 20, 2021
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Flumatinib, CML-CP with Ph+
Additional relevant MeSH terms:
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Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Myeloid
Leukemia
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
 Bone Marrow Diseases
Hematologic Diseases
HH-GV-678
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action