Actively Recruiting
A Phase Ib/II Clinical Trial on the Safety and Efficacy of TQB3909 Tablets in Patients With Recurrent or Refractory CLL/SLL
Led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. · Updated on 2023-10-23
107
Participants Needed
25
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of TQB3909 tablets in adults with recurrent or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). This phase Ib/II clinical trial aims to understand how this treatment works in patients whose disease has returned or not responded to previous therapies. The study is sponsored by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and includes participants aged 18 to 75 years. Participants will take TQB3909 tablets orally once a day at doses of either 400 mg or 600 mg in 28-day treatment cycles. Treatment continues until the disease worsens or unacceptable side effects occur. The trial does not include a placebo group and does not use masking or blinding methods. During the study, researchers will monitor participants for side effects and response to treatment for up to 34 months. They will assess safety through adverse event reporting and laboratory tests, and measure treatment effects by looking at remission rates, disease progression, and survival outcomes. Blood samples will be collected to study drug levels and potential biomarkers. Participants will be followed closely throughout the treatment and observation periods.
CONDITIONS
Brief Title
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) .
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteers who have signed informed consent and show good compliance
- Age between 18 and 75 years with an ECOG Performance Status score of 0-1
- Diagnosed with CLL or SLL based on 2018 International Workshop on Chronic Lymphocytic Leukemia guidelines
- Measurable lesions shown by CT or MRI in patients with SLL
- Female participants of childbearing potential agree to use contraception during the study and for 6 months after
- Negative pregnancy test within 7 days before enrollment
You will not qualify if you...
- History of other malignant tumors within 3 years, except certain cured cancers or those disease-free for 5 years
- Known involvement of lymphoma or leukemia in the central nervous system
- Prior allogeneic stem cell transplant or recent autologous stem cell transplant within 3 months
- Unresolved toxic reactions of grade 1 or higher from previous treatments
- Arterial or venous thrombotic events within 6 months before starting study medication
- Serious or uncontrollable diseases
- Recent chemotherapy, radiotherapy, immune checkpoint inhibitors, CAR-T therapy, or small molecule antitumor treatments within specified timeframes
- Previous treatment with BCL-2 inhibitors
- Vaccination within 4 weeks before first medication or planned during the study
- Participation in other antineoplastic drug trials within 4 weeks before first medication
- Allergies to allopurinol or benzbromarone
- Any condition judged by investigators to endanger safety or affect study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 28-day cycles until disease progression or discontinuation
Participants take TQB3909 tablets orally once a day in 28-day cycles. Treatment continues until the disease progresses or intolerable toxicity appears.
Visits occur as needed for medication administration and monitoring during treatment cycles
Duration - Up to 34 months
Participants are monitored for safety and efficacy outcomes after treatment ends.
Visits scheduled periodically up to 34 months to monitor adverse events and disease status
Trial Site Locations
Total: 25 locations
1
Anqing Municipal Hospital
Anqing, Anhui, China, 246004
Actively Recruiting
2
Gansu province Wuwei tumour hospital
Wuwei, Gansu, China, 733000
Actively Recruiting
3
Sun Yat-Sen University Cancer Canter
Guangzhou, Guangdong, China, 510060
Actively Recruiting
4
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China, 067400
Actively Recruiting
5
Harbin first hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
6
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Actively Recruiting
7
Henan Cancer Hospital
Zhengzhou, Henan, China, 450003
Actively Recruiting
8
Hunan Cancer Hospital
Changsha, Hunan, China, 410029
Actively Recruiting
9
Jiangsu Provincial People's Hospital
Nanjing, Jiangsu, China, 210029
Actively Recruiting
10
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215004
Actively Recruiting
11
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215006
Actively Recruiting
12
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Actively Recruiting
13
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Actively Recruiting
14
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China, 110000
Actively Recruiting
15
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250063
Actively Recruiting
16
Linyi people's hospital
Linyi, Shandong, China, 276002
Actively Recruiting
17
Tai 'an Central Hospital
Tai’an, Shandong, China, 271000
Actively Recruiting
18
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China, 200050
Actively Recruiting
19
Peace Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi, China, 460000
Actively Recruiting
20
Affiliated hospital of southwest medical university
Luzhou, Sichuan, China, 646000
Actively Recruiting
21
Mianyang Central Hospital
Mianyang, Sichuan, China, 621000
Actively Recruiting
22
Yibin Second People's Hospital
Yibin, Sichuan, China, 644000
Actively Recruiting
23
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
24
The First Affiliated Hospital of Xinjiang Medical University
Ürümqi, Xinjiang Uygur Autonomous Region, China, 830054
Actively Recruiting
25
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315010
Actively Recruiting
Research Team
J
Jianyong Li, Doctor
K
Keshu Zhou, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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