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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
olverembatinib, 40mg, taken orally once every other day of a 28-day cycle
Shenzhen Second People's Hospital
Shenzhen, Guangdong, China
RECRUITINGThe proportion of patients who achieve and maintain major molecular response(MMR) at 12 months using RQ-PCR test.
Major molecular response (MMR) is defined as BCR-ABL1 ≤ 0.1 percent.
Time frame: 12 months
The proportion of patients with MMR at 3, 6, 9 months.
Time frame: 3, 6, 9 months.
The proportion of patients with MR 4.0 at 3, 6, 9, 12 months.
Molecular response (MR) 4.0 is defined as BCR-ABL transcripts ≤ 0.01 percent.
Time frame: 3, 6, 9, 12 months.
Proportion of patients with MR 4.5 at 3, 6, 9, 12 months.
Molecular response (MR) 4.5 is defined as BCR-ABL transcripts ≤ 0.0032 percent.
Time frame: 3, 6, 9, 12 months.
Progression free survival (PFS)
PFS is defined as the interval between the first dose date and the first date at which the criteria for progression are met, or death.
Time frame: 12 months
Overall survive (OS)
OS is defined as the interval between the first dose date and date of death, censored at the last contact date to be alive.
Time frame: 12 months
Incidence of adverse events (AEs) and serious adverse events (SAEs) to Olverembatinib.
Evaluation of adverse events (AEs), serious AEs (SAEs)
Time frame: 12 months.
Xin Du, Phd
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