Tests TQB3911 tablets for safety in people with BCR::ABL leukemia
Tests TQB3911 tablets for safety and tolerance in adults with chronic myelogenous leukemia.
Plain-language title generated from the registry record
Registry title: A Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
Key facts
- Where
- Beijing, Hangzhou, Nanning, Shanghai, and Zhengzhou, ChinaSee the 5 sites
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with chronic myelogenous leukemia (CML) in the chronic or accelerated phase, who did not tolerate or did not respond well to earlier TKI drugs.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Chronic myelogenous leukemia in the chronic phase (CML-CP) or accelerated phase (AP)
- Earlier treatment
- Must not have tolerated tyrosine kinase inhibitor (TKI) drugs, or the treatment response was a failure
- Biomarker or test result
- BCR::ABL fusion gene positive leukemia
Main reasons for not taking part
- Another cancer within 5 years before the first medication
- Active leukemia in the central nervous system
- CML-CP with a complete cytogenetic response (CCyR)
- Heart problems such as a heart attack, pulmonary hypertension or angina within 3 months, or serious rhythm problems
- Acute pancreatitis, or chronic pancreatitis within 12 months
Read by machine on 9 November 2026.
Where in China
- Peking University People's HospitalBeijing, ChinaNo longer taking part
- The First Affiliated Hospital of Zhejiang University School of MedicineHangzhou, ChinaNo longer taking part
- The First Affiliated Hospital of Guangxi Medical UniversityNanning, ChinaNo longer taking part
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaNo longer taking part
- Henan Cancer HospitalZhengzhou, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Trial code
- NCT06672263
- Record updated
- 4 November 2024
- Original description
Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.Read full original descriptionShow less
Phase I Clinical Trial to Evaluate the Safety and Tolerability of TQB3911 Tablets in Patients With BCR::ABL Fusion Gene Positive Leukemia
Phase I clinical trial to explore the safety, tolerability, and initial efficacy of TQB3911 tablets in BCR::ABL fusion gene positive leukemia.
Inclusion: 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: 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; Received live attenuated vaccine within 4 weeks before the first dose, or planned to receive live attenuated vaccine during study participation; Had or was currently suffering from other malignant tumors within 5 years before the first medication; History of interstitial lung disease, radiation pneumonia requiring steroid treatment, or drug-related pneumonia; 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; Combined with active central nervous system leukemia; Patients with CML-CP who have achieved complete cytogenetic response (CCyR).