Trial 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) .
NCT ID:
NCT05959694
Condition:
Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
TQB3909 tablet
Description:
TQB3909 is an inhibitor targeting at B-cell lymphoma (BCL)-2 protein.
Arm group label:
TQB3909 tablets
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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;
Exclusion Criteria:
- Complicated diseases and medical history:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Anqing Municipal Hospital
Address:
City:
Anqing
Zip:
246004
Country:
China
Status:
Recruiting
Contact:
Last name:
Fusheng Yao, Doctor
Phone:
18955682626
Email:
yfsh3792@sina.com
Facility:
Name:
Gansu province Wuwei tumour hospital
Address:
City:
Wuwei
Zip:
733000
Country:
China
Status:
Recruiting
Contact:
Last name:
Cong Wang, Bachelor
Phone:
13893510690
Email:
58589473@qq.com
Facility:
Name:
Sun Yat-Sen University Cancer Canter
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhiming Li, Doctor
Phone:
+86 13719189172
Email:
lzmlzmlzm@yahoo.com
Facility:
Name:
Affiliated Hospital of Chengde Medical College
Address:
City:
Chengde
Zip:
067400
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhihua Zhang, Master
Phone:
156333142905
Email:
zzhangzhihua@163.com
Facility:
Name:
Harbin first hospital
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Tiejun Gong, Master
Phone:
13836027737
Email:
arc@sina.con
Facility:
Name:
The Second Affiliated Hospital of Harbin Medical University
Address:
City:
Harbin
Zip:
150000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wang Wei, Doctor
Phone:
13604880743
Email:
WW0543@163.com
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Recruiting
Contact:
Last name:
Keshu Zhou, Doctor
Phone:
+86 13674902391
Email:
drzhouks77@163.com
Facility:
Name:
Hunan Cancer Hospital
Address:
City:
Changsha
Zip:
410029
Country:
China
Status:
Recruiting
Contact:
Last name:
Yajun Li, Doctor
Phone:
19918803330
Email:
158316115@qq.com
Facility:
Name:
Jiangsu Provincial People's Hospital
Address:
City:
Nanjing
Zip:
210029
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianyong Li, Doctor
Phone:
+8613951877733
Email:
Ljianyonglm@mcdmail.com
Facility:
Name:
The Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Recruiting
Contact:
Last name:
Bingzong Li, Doctor
Phone:
13776054037
Email:
lbzwz0907@hotmail.com
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Recruiting
Contact:
Last name:
Zhengming Jin, Bachelor
Phone:
13862553199
Email:
jinzhengming519519@163.com
Facility:
Name:
Affiliated Hospital of Xuzhou Medical University
Address:
City:
Xuzhou
Zip:
221000
Country:
China
Status:
Recruiting
Contact:
Last name:
Feng Zhu, Doctor
Phone:
13852439312
Email:
Frankfeng_2004@126.com
Facility:
Name:
Jiangxi Cancer Hospital
Address:
City:
Nanchang
Zip:
330029
Country:
China
Status:
Recruiting
Contact:
Last name:
Wuping Li, Doctor
Phone:
13870659916
Email:
18907001021@163.com
Facility:
Name:
Shengjing Hospital Affiliated to China Medical University
Address:
City:
Shenyang
Zip:
110000
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Yang, Doctor
Phone:
18940251012
Email:
yangw@sj-hospital.org
Facility:
Name:
Qilu Hospital of Shandong University
Address:
City:
Jinan
Zip:
250063
Country:
China
Status:
Recruiting
Contact:
Last name:
Jie Li, Doctor
Phone:
18560082232
Email:
jieli6688@163.com
Facility:
Name:
Linyi people's hospital
Address:
City:
Linyi
Zip:
276002
Country:
China
Status:
Recruiting
Contact:
Last name:
Haiyan Zhang, Master
Phone:
13869986288
Email:
13869986288@163.com
Facility:
Name:
Tai 'an Central Hospital
Address:
City:
Tai'an
Zip:
271000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qingliang Teng, Master
Phone:
13375388422
Email:
tatql@163.com
Facility:
Name:
Shanghai Tongren Hospital
Address:
City:
Shanghai
Zip:
200050
Country:
China
Status:
Recruiting
Contact:
Last name:
Ligen Liu, Master
Facility:
Name:
Peace Hospital Affiliated to Changzhi Medical College
Address:
City:
Changzhi
Zip:
460000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xuliang Shen, Doctor
Phone:
13015365546
Email:
shenxlcyp@sohu.com
Facility:
Name:
Affiliated hospital of southwest medical university
Address:
City:
Luzhou
Zip:
646000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoming Li, Master
Phone:
13700986866
Email:
LXM6358@21.com.cn
Facility:
Name:
Mianyang Central Hospital
Address:
City:
Mianyang
Zip:
621000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaobo Du, Doctor
Phone:
13550822229
Email:
Duxiaobo2005@126.com
Facility:
Name:
Yibin Second People's Hospital
Address:
City:
Yibin
Zip:
644000
Country:
China
Status:
Recruiting
Contact:
Last name:
Sihua Huang, Bachelor
Phone:
18284820022
Facility:
Name:
Tianjin Cancer Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yafei Wang, Doctor
Phone:
18622221250
Email:
Drwang2005@163.com
Facility:
Name:
The First Affiliated Hospital of Xinjiang Medical University
Address:
City:
Ürümqi
Zip:
830054
Country:
China
Status:
Recruiting
Contact:
Last name:
Jianhua Qu, Master
Phone:
13199855506
Email:
jhuaqu@163.com
Facility:
Name:
The First Affiliated Hospital of Ningbo University
Address:
City:
Ningbo
Zip:
315010
Country:
China
Status:
Recruiting
Contact:
Last name:
Guifang Ouyang, Master
Phone:
13967810405
Email:
nbougf@163.com
Start date:
October 11, 2023
Completion date:
June 2026
Lead sponsor:
Agency:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Agency class:
Industry
Source:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05959694
