A Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory Chronic Lymphocytic Leukemia (CLL) /Small Lymphocytic Lymphoma (SLL) .
NCT ID: NCT05959694
Last Updated: 2023-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
107 participants
INTERVENTIONAL
2023-10-11
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TQB3909 tablets
Oral administration, 400mg or 600 mg, once a day, and 28 days is a treatment cycle. Continue medication until the disease progresses or intolerant toxicity appears.
TQB3909 tablet
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
Interventions
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TQB3909 tablet
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
Eligibility Criteria
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Inclusion Criteria
* Age: ≥ 18 years old, ≤75 years old (when signing ICF); Eastern Cooperative Oncology Group Performance Status (ECOG PS) score: 0-1; The expected survival period is more than 3 months;
* Subjects: patients diagnosed as CLL/SLL according to the revised diagnostic criteria of 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) guidelines;
* Computed Tomography / Magnetic Resonance Imaging (CT/MRI) of patients with SLL showed measurable lesions;
* Female subjects of childbearing age should agree to use contraceptive measures (such as 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 7 days before study enrollment;
Exclusion Criteria
1. It has appeared or is currently suffering from other malignant tumors within 3 years before the first medication. The following two situations can be included in the group: other malignant tumors treated by single surgery have achieved disease-free survival (DFS) for five consecutive years; Cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumor \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
2. Lymphoma/leukemia is known to involve the central nervous system (CNS);
3. Previously received allogeneic hematopoietic stem cell transplantation;
4. Received autologous hematopoietic stem cell transplantation within 3 months before the first medication;
5. Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
6. Arterial/venous thrombotic events occurred within 6 months before the first medication, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
7. Subjects with any serious and/or uncontrollable diseases;
* Tumor-related symptoms and treatment:
1. He has received chemotherapy and radiotherapy within 4 weeks before the first medication, immune checkpoint inhibitor and Chimeric Antigen Receptor T (CAR-T)-Cell Immunotherapy within 12 weeks before the first medication, and other small molecule anti-tumor treatments (the elution period is calculated from the end of the last treatment) before the first medication are within 5 half-lives;
2. previously received BCL-2 inhibitors;
* Research-related treatment: received the vaccine within 4 weeks before the first medication, or planned to be vaccinated during the study;
* Participated in clinical trials of other antineoplastic drugs within 4 weeks before the first medication;
* According to the investigators' judgment, there are patients with accompanying diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who think that there are other reasons that are not suitable for inclusion.
* Allergic to allopurinol and benzbromarone.
18 Years
75 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Anqing Municipal Hospital
Anqing, Anhui, China
Gansu province Wuwei tumour hospital
Wuwei, Gansu, China
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
Harbin first hospital
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
Linyi people's hospital
Linyi, Shandong, China
Tai 'an Central Hospital
Tai’an, Shandong, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China
Affiliated hospital of southwest medical university
Luzhou, Sichuan, China
Mianyang Central Hospital
Mianyang, Sichuan, China
Yibin Second People's Hospital
Yibin, Sichuan, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Ligen Liu, Master
Role: primary
Sihua Huang, Bachelor
Role: primary
Other Identifiers
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TQB3909-Ib/II-02
Identifier Type: -
Identifier Source: org_study_id
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