Phase
Condition
Lymphocytic Leukemia, Chronic
Marginal Zone Lymphoma
Leukemia
Treatment
TQB3909 tablet
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subjects volunteered to join the study and signed informed consent form (ICF) withgood compliance;
- Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative OncologyGroup Performance Status (ECOG PS) score: 0-1; The expected survival period is morethan 3 months;
- Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteriaof 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
- Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showedmeasurable lesions;
- Female subjects of childbearing age should agree to use contraceptive measures (suchas intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; serum pregnancy/urine pregnancy test within 7days before study enrollment;
Exclusion
Exclusion Criteria:
- Complicated diseases and medical history:
- It has appeared or is currently suffering from other malignant tumors within 3years before the first medication. The following two situations can be includedin the group: other malignant tumors treated by single surgery have achieveddisease-free survival (DFS) for five consecutive years; Cured cervical carcinomain situ, non-melanoma skin cancer and superficial bladder tumor [Ta (non-invasivetumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)];
- Lymphoma/leukemia is known to involve the central nervous system (CNS);
- Previously received allogeneic hematopoietic stem cell transplantation;
- Received autologous hematopoietic stem cell transplantation within 3 monthsbefore the first medication;
- Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
- Arterial/venous thrombotic events occurred within 6 months before the firstmedication, such as cerebrovascular accidents (including transient ischemicattack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis andpulmonary embolism;
- Subjects with any serious and/or uncontrollable diseases;
- Tumor-related symptoms and treatment:
- He has received chemotherapy and radiotherapy within 4 weeks before the firstmedication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and othersmall molecule anti-tumor treatments (the elution period is calculated from theend of the last treatment) before the first medication are within 5 half-lives;
- previously received BCL-2 inhibitors;
- Research-related treatment: received the vaccine within 4 weeks before the firstmedication, or planned to be vaccinated during the study;
- Participated in clinical trials of other antineoplastic drugs within 4 weeks beforethe first medication;
- According to the investigators' judgment, there are patients with accompanyingdiseases that seriously endanger the safety of the subjects or affect the completionof the study, or subjects who think that there are other reasons that are not suitablefor inclusion.
- Allergic to allopurinol and benzbromarone.
Study Design
Connect with a study center
Anqing Municipal Hospital
Anqing, Anhui 246004
ChinaActive - Recruiting
Gansu province Wuwei tumour hospital
Wuwei, Gansu 733000
ChinaActive - Recruiting
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong 510060
ChinaActive - Recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei 067400
ChinaActive - Recruiting
Harbin first hospital
Harbin, Heilongjiang 150000
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150000
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450003
ChinaActive - Recruiting
Hunan Cancer Hospital
Changsha, Hunan 410029
ChinaActive - Recruiting
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu 210029
ChinaActive - Recruiting
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215006
ChinaActive - Recruiting
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu 215004
ChinaActive - Recruiting
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu 221000
ChinaActive - Recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi 330029
ChinaActive - Recruiting
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning 110000
ChinaActive - Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong 250063
ChinaActive - Recruiting
Linyi people's hospital
Linyi, Shandong 276002
ChinaActive - Recruiting
Tai 'an Central Hospital
Tai'an, Shandong 271000
ChinaActive - Recruiting
Shanghai Tongren Hospital
Shanghai, Shanghai 200050
ChinaActive - Recruiting
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi 460000
ChinaActive - Recruiting
Affiliated hospital of southwest medical university
Luzhou, Sichuan 646000
ChinaActive - Recruiting
Mianyang Central Hospital
Mianyang, Sichuan 621000
ChinaActive - Recruiting
Yibin Second People's Hospital
Yibin, Sichuan 644000
ChinaActive - Recruiting
Tianjin Cancer Hospital
Tianjin, Tianjin 300060
ChinaActive - Recruiting
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region 830054
ChinaActive - Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang 315010
ChinaActive - Recruiting
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