Phase
Condition
Lymphoma
Mantle Cell Lymphoma
Lymphoproliferative Disorders
Treatment
600mg of TQB3909 tablets
400mg of TQB3909 tablets
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- The subject voluntarily joins the study, signs the informed consent form, and has goodcompliance;
- Age: ≥ 18 years old (when signing the informed consent form); Eastern CooperativeOncology Group performance status (ECOG PS) score: 0-2 points; Expected survival ismore than 3 months;
- Subject population: Confirmed as MCL by local laboratory pathology and independentpathology review (stage 2).
- The main organs are functioning well,
- The patient's Computed Tomography (CT) / Magnetic Resonance Imaging (MRI) showsmeasurable lesions, defined as ≥ 1 lymph node with the longest diameter of > 1.5 cm or ≥ 1 extranodal lesion with the longest diameter of > 1.0 cm, which can be measured by ≥ 2 vertical dimensions;
- Female subjects of childbearing age should agree to use contraception (e.g., pills, orcondoms) during the study and for 6 months after the end of the study; Have a negativeserum pregnancy test within 7 days prior to study enrollment and must be anon-lactating subject; Male participants should agree that contraception must be usedduring the study period and for 6 months after the end of the study period.
Exclusion
Exclusion Criteria:
- Have had or currently have other malignant tumors within 3 years before the first doseof study drug.
- It is known that lymphoma affects the central nervous system (CNS);
- Previous allogeneic hematopoietic stem cell transplantation;
- Have received autologous hematopoietic stem cell transplantation within 3 monthsbefore the first dose of study drug;
- There are a variety of factors that affect oral drugs (such as inability to swallow,chronic diarrhea and intestinal obstruction, inflammatory bowel disease, malabsorptionsyndrome, etc.);
- Unmitigated toxicity ≥ Common Terminology Criteria for Adverse Events (CTCAE) grade 2due to any prior treatment (except hair loss, absolute neutrophil count and plateletabnormalities, which follow the inclusion criteria 4);
- Significant surgical treatment and obvious traumatic injury within 28 days prior tothe start of study treatment;
- Arteriovenous thrombotic events within 3 months before the first dose, such ascerebrovascular accident (including cerebral hemorrhage, cerebral infarction, exceptlacunar cerebral infarction), deep vein thrombosis (except secondary to deep veincatheterization) and pulmonary embolism;
- Those who have a history of psychotropic substance abuse and cannot be withdrawn orhave mental disorders;
- Subjects with any severe and/or uncontrolled medical conditions, including:
- Grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (Quick Time ConstantFluctuation (QTcF) >450 ms in men, QTcF >470 ms in women) and grade ≥2 congestiveheart failure (New York Heart Association (NYHA) grade), cardiac ultrasound assessmentof left ventricular ejection fraction (LVEF) of <50%; poorly controlled hypertension,defined as systolic blood pressure > 170 mmHg and diastolic blood pressure > 105 mmHgat least 2 consecutive blood pressure measurements at the time of screening;
- presence of active infection (≥ CTCAE grade 2 infection);
- active hepatitis; Hepatitis B virus (HBV) infection, HBV DNA positive or copy numberexceeding the upper limit of normal values in the research center;
- Have a history of immunodeficiency, including Human ImmunodeficiencyVirus(HIV)-positive or other acquired or congenital immunodeficiency diseases, or havea history of organ transplantation;
- Those who have epilepsy and need treatment.
- Have received chemotherapy and radiotherapy within 4 weeks before the first dose,received immune checkpoint inhibitors and Chimeric Antigen Receptor T-CellImmunotherapy (CAR-T) therapy 12 weeks before the first dose, and received other smallmolecule antitumor therapy (elution period from the end of the last treatment) beforethe first drug use within 5 half-lives;
- Previous treatment with BCL-2 inhibitors;
- Have received a live vaccine within 4 weeks prior to the first dose, or plan to bevaccinated during the study;
- Have participated in other antitumor drug clinical trials within 4 weeks before thefirst dose;
- According to the judgment of the investigator, there are concomitant diseases thatseriously endanger the safety of subjects or affect the completion of the study, orsubjects who are considered to be unsuitable for enrollment for other reasons.
- Allergic to allopurinol and benzbromarone.
Study Design
Connect with a study center
Peking University Third Hospital
Beijing, Beijing 100191
ChinaActive - Recruiting
Chongqing University Hospital
Chongqing, Chongqing 400030
ChinaActive - Recruiting
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian 361003
ChinaActive - Recruiting
Gansu Provincial Cancer Hospital
Lanzhou, Gansu 730050
ChinaActive - Recruiting
Guangxi Medical University Cancer Hospital
Nanning, Guangxi 530021
ChinaActive - Recruiting
The Affiliated Hospital of Chengde Medical College
Chengde, Hebei 067000
ChinaActive - Recruiting
Affiliated Cancer Hospital of Harbin Medical University
Harbin, Heilongjiang 150081
ChinaActive - Recruiting
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang 150001
ChinaActive - Recruiting
Henan Cancer Hospital
Zhengzhou, Henan 450000
ChinaActive - Recruiting
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei 430050
ChinaActive - Recruiting
The Affiliated Hospital of Xuzhou Medical University
Nanjing, Jiangsu 220005
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
Jinzhou Central Hospital
Wuxi, Jiangsu 530031
ChinaActive - Recruiting
Jilin Cancer Hospital
Changchun, Jilin 130012
ChinaActive - Recruiting
The First Hospital of Jilin University
Changchun, Jilin 130022
ChinaActive - Recruiting
The Second Hospital of Dalian Medical University
Dalian, Liaoning 116000
ChinaActive - Recruiting
Binzhou Medical University Hospital
Binzhou, Shandong 256603
ChinaActive - Recruiting
Linyi People's Hospital
Linyi, Shandong 276000
ChinaActive - Recruiting
Shanghai Huashan Hospital
Shanghai, Shanghai 200040
ChinaActive - Recruiting
Tongji hospital of Tongji University
Shanghai, Shanghai 200065
ChinaActive - Recruiting
Heping Hospital Affiliated to Changzhi Medical College
Changzhi, Shanxi 046000
ChinaActive - Recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan 646000
ChinaActive - Recruiting
Institute of Dematology & Blood diseases Hospital
Tianjin, Tianjin 300052
ChinaActive - Recruiting
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin 300040
ChinaActive - Recruiting
Xinjiang Uygur Autonomous Region People's Hospital
Ürümqi, Xinjiang 830001
ChinaActive - Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang 310003
ChinaActive - Recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang 215006
ChinaActive - Recruiting
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