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
|Condition or disease||Intervention/treatment||Phase|
|Flumatinib Chronic Myeloid Leukemia, Chronic Phase Imatinib||Drug: Flumatinib||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
600 mg of Flumatinib orally daily for 24 months
- 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.
- 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.
- 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.
- Proportion of patients with MMR at 3, 6, 9 months. [ Time Frame: 3, 6, 9 months ]
- 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.
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
|Contact: Xin Du, Phdfirstname.lastname@example.org|
|The Second People's Hospital of Shenzhen||Recruiting|
|Shenzhen, Guangdong, China, 518035|
|Principal Investigator:||Xin Du, Phd||Shenzhen Second People's Hospital|