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About
The purpose of this study is to evaluate the efficacy of HQP1351 in patients with chronic myeloid leukemia in accelerated phase (CML-AP) harboring T315I mutation. The efficacy of HQP1351 was determined by evaluating the subjects' major hematologic response (MaHR).
Full description
This is an open, single-arm, multi-center phase 2 clinical study to evaluate the efficacy and safety of oral administrated of HQP1351(40mg, QOD) in CML-AP patients with T315I mutation in China. A total of 20 CML-AP patients will be included in this pivotal study. After screening, eligible subjects will receive oral HQP1351 40mg on a continues once every other day dosing regimen, until disease progression, drug intolerance, or meet other treatment conditions to discontinue the study. During the course of treatment, each subject will be assessed regularly for hematological, cytogenetic and molecular responses. At the same time, safety information also will be evaluated.
Enrollment
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Inclusion criteria
Male or non-pregnant, non-lactating female patients who are 18 years of age or older.
CML-AP patients with positive Ph chromosome or BCR-ABL fusion genes.
After any targeted BCR-ABL1 tyrosine kinase inhibitors (TKI) treatment, CML-AP patients with T315I mutation.
Ability to understand and willingness to sign a written informed consent form. The consent form must be signed by the patient prior to any study-specific procedures.
Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
Predicted life expectancy of ≥3 months.
Organ function as indicated by the following laboratory indicators must be met(Hematological indicators require that no blood transfusion or any blood products or cytokines be used within 14 days prior to testing):
Cardiac function index: ejection fraction (EF) > 50%, pulmonary arterial systolic pressure (PASP) ≤50 mmHg.
QT interval corrected on electrocardiogram (ECG) evaluation: QTc≤450ms in males or ≤470ms in females.
Males and females of childbearing potential and their partners voluntarily take contraceptive measures that the researchers believe are effective within 120 days from the signing of the informed consent to the last use of the research drug, or confirm that sterilization has been performed (at least one month before screening).
Willingness and ability to comply with study procedures and follow-up examination.
Exclusion criteria
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23 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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