Status:
UNKNOWN
Evaluating Efficacy and Safety of Flumatinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning,Failure) to Imatinib or Dasatinib
Lead Sponsor:
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Conditions:
CML-CP; Mutation;Suboptimal Response or Failure in TKI
Eligibility:
All Genders
18+ years
Brief Summary
Imatinib has revolutionized the treatment of chronic myeloid leukemia (CML) and is the current standard of care in the treatment of patients with newly diagnosed CML. However, about 30% of patients st...
Eligibility Criteria
Inclusion
- Male or female patients ≥18 years of age;
- CML-CP patients when enrolled
- Definition of diagnosis:
- Bone marrow cytogenetic confirmation of Philadelphia chromosome of t (9;22) translocations and/or the presence of P210 BCR-ABL1 transcripts via molecular assessment;
- Documented chronic phase CML will meet all the criteria defined as:
- \< 15% blasts in peripheral blood and bone marrow \< 30% blasts plus promyelocytes in peripheral blood and bone marrow \< 20% basophils in the peripheral blood
- ≥ 100 x 109/L (≥ 100,000/mm3) platelets No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly
- CML-CP patients without optimal response(warning or failure) when treated with imatinib or dasatinib.
- Female patients of childbearing potential must have a negative serum pregnancy test;
- Ability to provide written informed consent prior to any study related screening procedures being performed.
Exclusion
- Treatment with other tyrosine kinase inhibitor(s) except imatinib and dasatinib prior to study entry;
- With any mutations as follows :T315I、Y253F/H、E255K/V、F359C/V/I (if there are any other mutations,at physicians' discretion );
- Entry into another therapeutic clinical trial;
- Concomitant diseases that, according to the investigator's judgment, pose a serious risk to the patient's safety or completion of the study;
- History of neurological or psychiatric disorders, including epilepsy or dementia;
- Major surgery within 4 weeks prior to Day 1 of study;
- Patients with another primary malignancy,unless the other primary malignancy is currently stable or does not need active intervention;
- Women of reproductive age or men who are unable to use adequate methods of contraception, including women who are pregnant or breastfeeding;
- ECOG≥3;
- Patients who are unable to compliance with study or follow-up procedures;
- Allergic to any of the components in this trial;
- Not appropriate to attend this trial judged by the investigator.
Key Trial Info
Start Date :
November 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 1 2024
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04681820
Start Date
November 1 2020
End Date
November 1 2024
Last Update
August 1 2023
Active Locations (1)
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1
Weiming Li
Wuhan, Hubei, China