Treatment With Olverembatinib in CML-CP Patients Who Failed to at Least Two Previously Administered Second-generation TKIs.

  • STATUS
    Recruiting
  • End date
    Jun 30, 2025
  • participants needed
    40
  • sponsor
    Shenzhen Second People's Hospital
Updated on 4 October 2022

Summary

The purpose of this trial is to evaluate the efficacy and safety of olverembatinib(HQP1351) in patients with chronic myeloid leukemia in chronic phase (CML-CP) who are resistant and/or intolerant to at least two second-generation tyrosine kinase inhibitors. The efficacy of olverembatinib is determined by evaluating the major molecular responses(MMR) at the and of 12 months.

Details
Condition Olverembatinib, Chronic Myeloid Leukemia, Chronic Phase, Tyrosine Kinase Inhibitors
Treatment olverembatinib
Clinical Study IdentifierNCT05311943
SponsorShenzhen Second People's Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age ≥ 18 years and ≤75 years
Diagnosis of CML-CP
ECOG performance of 0-2
Adequate end organ function defined as the following: total bilirubin <1.5xULN, SGPT <2.5x ULN, creatinine <1.5x ULN
Resistance and/or intolerance of at least two second-generation TKIs
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

Known to be allergic to study drug ingredients or their analogues
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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