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) .
A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL.
1 other identifier
interventional
107
1 country
25
Brief Summary
This is a phase Ib/II clinical trial to evaluate the safety and efficacy of TQB3909 tablets in patients with recurrent or refractory CLL/SLL.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2023
Typical duration for phase_1
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2023
CompletedFirst Posted
Study publicly available on registry
July 25, 2023
CompletedStudy Start
First participant enrolled
October 11, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
CompletedOctober 23, 2023
June 1, 2023
2.1 years
July 17, 2023
October 19, 2023
Conditions
Outcome Measures
Primary Outcomes (8)
Incidence of adverse events (AE)
Incidence of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of adverse events (AE)
Severity of AE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Incidence of serious adverse events (SAE)
Incidence of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of serious adverse events (SAE)
Severity of SAE evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Incidence of abnormal laboratory examination indexes.
Incidence of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Severity of abnormal laboratory examination indexes.
Severity of abnormal laboratory examination indexes evaluated by CTCAE 5.0 (Common Terminology Criteria for Adverse Events 5.0).
Up to 34 months.
Recommended phase II dose (RP2D)
To determine the recommended phase II dose of TQB3909 tablets in the treatment of recurrent or refractory CLL/SLL.
Up to 18 months
Objective remission rate (ORR) determined by Independent Review Committee (IRC)
Determine the objective remission rate (ORR) based on the evaluation results of the Independent Review Committee (IRC), defined as the proportion of subjects whose best remission is complete remission (CR) and partial remission (PR).
Up to 34 months
Secondary Outcomes (12)
Objective remission rate (ORR) determined by the investigators' evaluation.
Up to 34 months
Duration of remission (DOR)
Up to 34 months
Time to disease progression (TTP)
Up to 34 months
Time to remission (TTR)
Up to 34 months
Progression-free survival (PFS)
Up to 34 months
- +7 more secondary outcomes
Study Arms (1)
TQB3909 tablets
EXPERIMENTALOral 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.
Interventions
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
Eligibility Criteria
You may qualify if:
- The subjects volunteered to join the study and signed informed consent form (ICF) with good compliance;
- 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;
You may not qualify if:
- Complicated diseases and medical history:
- 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 \[Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor infiltrating basement membrane)\];
- 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 months before the first medication;
- Unresolved toxic reaction ≥ CTCAE grade 1 caused by any previous treatment;
- 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;
- Subjects with any serious and/or uncontrollable diseases;
- Tumor-related symptoms and treatment:
- 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;
- 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;
- Allergic to allopurinol and benzbromarone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Anqing Municipal Hospital
Anqing, Anhui, 246004, China
Gansu province Wuwei tumour hospital
Wuwei, Gansu, 733000, China
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, 510060, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, 067400, China
Harbin first hospital
Harbin, Heilongjiang, 150000, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Henan Cancer Hospital
Zhengzhou, Henan, 450003, China
Hunan Cancer Hospital
Changsha, Hunan, 410029, China
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215006, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110000, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250063, China
Linyi people's hospital
Linyi, Shandong, 276002, China
Tai 'an Central Hospital
Tai’an, Shandong, 271000, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200050, China
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, 460000, China
Affiliated hospital of southwest medical university
Luzhou, Sichuan, 646000, China
Mianyang Central Hospital
Mianyang, Sichuan, 621000, China
Yibin Second People's Hospital
Yibin, Sichuan, 644000, China
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, 300060, China
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, 830054, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315010, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2023
First Posted
July 25, 2023
Study Start
October 11, 2023
Primary Completion
December 1, 2025
Study Completion
June 1, 2026
Last Updated
October 23, 2023
Record last verified: 2023-06