B-cell Lymphoma
Conditions
Brief summary
To evaluate the efficacy and safety of TQB3702 tablets combined with immunochemotherapy for the treatment of B-cell lymphoma
Interventions
DRUGTQB3702 tablets+Chemotherapy regimen
TQB3702 tablets: Tyrosine kinase inhibitor； Chemotherapy regimen：inhibiting tumor cell proliferation, suppressing DNA synthesis, inducing cell apoptosis, enhancing immune system function, and inhibiting angiogenesis；
Sponsors
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* The subjects voluntarily joined the study, signed the informed consent, and the compliance was good; * Age: 18 years old ≤ age (when signing the informed consent) ≤75 years old; Eastern cooperative oncology group (ECOG) score: 0-2; Expected survival of more than 3 months; * Histologically confirmed B-cell lymphomas of the following types that meet the 2022 World Health Organization (WHO) diagnostic criteria: 1. Relapsed/refractory indolent B-cell lymphoma 2. Diffuse large B cell lymphoma（DLBCL） * Previous treatment: Relapsed/refractory inert B-cell lymphoma: have received at least one previous line of systemic standard therapy * Have at least one measurable lesion. * The main organs function well. * Female subjects of reproductive age should agree to use contraception (such as Iuds, contraceptives, or condoms) during the study period and for 6 months after the end of the study; Have a negative serum pregnancy test within 7 days prior to study enrollment and must be a non-lactating subject; Male subjects should agree to use avoidance during the study period and for 6 months after the end of the study period.
Exclusion criteria
* Have had or are currently suffering from other malignant tumors within 3 years prior to the first medication. * Known or suspected central nervous system (CNS) aggression. * Relapsed/refractory inert B-cell lymphoma: previous allogeneic hematopoietic stem cell transplantation, or autologous hematopoietic stem cell transplantation within 3 months before the first treatment; * Recurrent/refractory indolent B-cell lymphoma: toxic reactions that do not return to ≤ National Cancer Institute standard for common toxic reactions (NCI-CTC) AE Grade 1 due to any previous treatment, excluding hair loss and fatigue; * Have multiple factors that affect oral drug absorption (such as inability to swallow, chronic diarrhea, and intestinal obstruction); * Received major surgical treatment or significant traumatic injury within 28 days before the start of study treatment; * Hyperkinetic/venous thrombosis events occurred within 6 months before the first medication; * Have a history of psychotropic drug abuse and can not quit or have mental disorders; * Subjects with any severe and/or uncontrolled disease; * Received live vaccine or messenger ribonucleic acid (mRNA) vaccine within 4 weeks before the first dose, or planned to receive live vaccine or mRNA vaccine during the study; * Participated in clinical trials of other antitumor drugs within 4 weeks before the first medication; * Subjects who, in the judgment of the investigator, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or subjects who are not suitable for enrollment for other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | Up to 2 years | According to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.the proportion of subjects whose tumors are evaluated as complete response(CR) and partial response(PR) by subcenter imaging evaluation. It is recorded from the first use of the drug to disease progression or initiation of a new anticancer treatment. |
| Complete response rate (CRR) | Up to 2 years | The rate of complete tumor remission |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 1-year PFS and OS | Up to 1 year | 1-year Progression-free survival and Overall survival rates |
| Progression-free survival (PFS) | Up to 2 years | PFS defined as the time from first dose to the first documented progressive disease (PD) or death from any cause. |
| 2-years PFS and OS | Up to 2 years | 2-years Progression-free survival and Overall survival rates |
| Adverse events (AE) and serious adverse events (SAE) | Baseline to up to 28 days | Incidence and severity of adverse events (AE) and serious adverse events (SAE), as well as abnormal laboratory test indicators |
| ORR and CRR at the end of combination therapy | Up to 1 year | Objective response rate and complete remission rate at the end of combination therapy. |
| Duration of response (DOR) | Up to 2 years | The period from the participants first achieving CR or PR to disease progression |
| Overall survival (OS) | Up to all-cause death | OS is defined as the time from the first administration to all-cause death |
Countries
China
Contacts
Primary ContactZengjun Li, Doctor
Backup ContactFei Li, Doctor
Outcome results
None listed