A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Oct 31, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called TQB3911 in patients with a specific type of leukemia, known as Chronic Myelogenous Leukemia (CML), who have a particular genetic change called the BCR::ABL fusion gene. The main goals of this study are to see how safe the medication is, how well patients tolerate it, and if it shows any early signs of being effective in treating this type of leukemia. The trial is currently not recruiting participants, meaning it hasn't started yet.

To take part in this trial, participants need to be at least 18 years old and have been diagnosed with CML that hasn't responded well to standard treatments. They should also be in good health overall and able to follow study guidelines. Women of childbearing age must agree to use contraception during the study, while men must follow similar precautions. Participants will be closely monitored throughout the trial to ensure their safety and well-being. This is an important step in developing new treatments for leukemia, and while it might involve some risks, it also offers a chance to contribute to medical research that could help others in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • The subjects voluntarily joined the study, signed the informed consent, and had good compliance;
• • Age: ≥18 years old (when signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-2; Expected survival of more than 3 months;
• • During the screening period, the patients were identified as Chronic myelogenous leukemia-Chronic phase (CML-CP) or accelerated phase (AP) patients by bone marrow cell morphological examination, molecular biological examination or cytogenetic examination;
• • Chronic myelogenous leukemia (CML) patients who are intolerant to Tyrosine kinase inhibitors (TKI) drugs or whose therapeutic effect is not satisfactory (that is, the therapeutic response evaluation result is failure)
• • The main organs function well
• • Female subjects of reproductive age should agree to use contraceptives (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.
• Exclusion Criteria:
• • Had or was currently suffering from other malignant tumors within 5 years before the first medication
• • Combined with active central nervous system leukemia
• • Major surgical treatment and significant traumatic injury were received within 28 days before the start of study treatment
• • Previous history of myocardial infarction, pulmonary hypertension, or angina pectoris within 3 months before the first medication, or clinically significant arrhythmias such as ventricular tachycardia, complete left bundle branch block, and high atrioventricular block
• • Acute pancreatitis and a history of chronic pancreatitis within 12 months before the first medication
• • History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia
• • Patients with CML-CP who have achieved complete cytogenetic response (CCyR)
• • Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation
• • Use of drugs that may have caused QT prolongation or tip torsical tachycardia in the 7 days prior to initial administration, or continuation of these medications during the study period