Evaluating Efficacy and Safety of Flumatinib Versus Nilotinib for Chronic Phase Chronic Myeloid Leukemia(CML-CP) Without Optimal Response (Warning Failure) to Imatinib or Dasatinib

  • End date
    Nov 11, 2024
  • participants needed
  • sponsor
    Wuhan Union Hospital, China
Updated on 11 June 2021


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 still show drug resistance or disease progression. Currently, the most widely studied mechanism of TKI resistance in CML patients is mutations in the ABL kinase region. So far, more than 100 kinase domain mutations have been found in disease progression and imatinib resistance. It is estimated that more than 25% of CML patients will change TKI at least once in their lifetime due to drug resistance or intolerance. The 2020 edition of the "Guidelines for the Diagnosis and Treatment of Chronic Myelogenous Leukemia in China" proposes that patients with F317L/V/I/C, V299L and T315A mutations are more likely to obtain clinical efficacy by switching to the second-generation TKI nilotinib; patients with Y253H, E255K/V and F359C/V/I mutations are more likely to obtain clinical efficacy by switching to the second-generation TKI dasatinib; patients with T315I mutations are resistant to both nilotinib and dasatinib. Flumatinib has been shown to be a more potent inhibitor of BCR-ABL1 tyrosine kinase than imatinib. In vitro studies, it has shown that flumatinib inhibits wild-type and common BCR-ABL mutations(Q252H, V299L, F317L/I, M351T, H396P, etc.) more potently, and the anti-mutation spectrum of flumatinib is similar to nilotinib. Therefore, this study is designed to provide clearer guidance for patients with suboptimal response or failure in the treatment of TKI as well as those who have specific ABL kinase domain mutations during CML treatment.

Condition CML-CP; Mutation;TKI, CML-CP; Mutation;Suboptimal Response or Failure in TKI
Treatment Nilotinib, Flumatinib
Clinical Study IdentifierNCT04681820
SponsorWuhan Union Hospital, China
Last Modified on11 June 2021


Yes No Not Sure

Inclusion Criteria

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
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
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 Criteria

With any mutations as follows :T315IY253F/HE255K/VF359C/V/I (if there are any other mutations,at physicians' discretion )
Treatment with other tyrosine kinase inhibitor(s) except imatinib and dasatinib prior to study entry
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
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
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