About this trial
Evaluation of the efficacy and safety of TQB2825 injection compared to immunotherapy in the treatment of recurrent/refractory follicular lymphoma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Voluntarily join this study, sign the informed consent form (ICF), and have good compliance.
18 years old ≤ age<80 years old (calculated based on the date of signing the informed consent form); No gender restrictions; Eastern Cooperative Oncology Group Performance Status (ECOG) score 0-2.
Expected survival is greater than 6 months.
Follicular lymphoma (histological grade 1-3a) that meets the 2016 WHO diagnostic criteria or classic follicular lymphoma that meets the 2022 World Health Organization (WHO) diagnostic criteria, and immunophenotyping analysis shows CD20 positivity in the tumor.
Disqualifiers
Have had or currently have other malignant tumors within the previous 5 years of randomization. The following two situations can be included in the group: other malignant tumors that have been cured by a single surgery and have achieved continuous disease-free survival (DFS) for 5 years; Cured cervical carcinoma in situ, non melanoma skin cancer, and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ), and T1 (tumor infiltrating basement membrane)].
Lymphoma has previously or currently affected or is suspected to affect the central nervous system, or there is evidence of lymphoma leukemia present.
There is evidence of transformation into diffuse large B-cell lymphoma or other types of lymphoma (such as biopsy showing large cells or Positron Emission Tomography (PET) showing significant abnormal high metabolism in one/some lymph nodes).
Active hepatitis or decompensated cirrhosis (Child Pugh liver function rating B or C). (Note: active hepatitis B refers to positive HBsAg, and Hepatitis B Virus (HBV) DNA is positive or the test value exceeds the upper limit of normal value; Active hepatitis C refers to Hepatitis B Virus (HCV) antibody positivity, and HCV RNA positivity or detection value exceeding the upper limit of normal; The eligible subjects with positive hepatitis B HBsAg but HBV DNA not exceeding the upper limit of normal value, whether their HBV DNA is measurable or not, need to continue antiviral treatment (nucleoside analogues are recommended) and regularly monitor HBV DNA; For subjects with positive hepatitis B HBcAb but negative HBsAg, HBV DNA needs to be monitored regularly, and preventive antiviral treatment is recommended; For subjects who are positive for hepatitis C HCV antibodies but whose HCV RNA does not exceed the upper limit of normal values, regular monitoring of HCV RNA is required.
Trial design
Parallel
Treatments tested in this trial
TQB2825 Injection
DrugTQB2825 is a Cluster of Differentiation 3 (CD3) × Cluster of Differentiation 20 (CD20) bispecific antibody.
Rituximab Injection
DrugRituximab combined with Chemotherapy (Rituximab, Cyclophosphamide, doxorubicin, Vincristine, Prednisone, Ifosfamide, Gemcitabine, cisplatin, Carboplatin, Etoposide, MESNA, Dexamethasone)
Treatment groups
Trial outcomes
Primary outcomes
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Progression free survival (PFS) evaluated by an independent review committee (IRC)
Secondary outcomes
Objective response rate (ORR)
The percentage of complete (CR) or partial response (PR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively
Complete response rate (CR rate)
The percentage of complete (CR) subjects determined by IRC based on the 2014 Lugano criteria or by researchers based on the 2014 Lugano criteria and LYRIC, respectively.
Progression free survival (PFS) evaluated by researchers
The time from randomization to researcher evaluation of disease progression or death from any cause (whichever occurs first) is determined according to the 2014 Lugano criteria and LYRIC.
Time to relief (TTR)
The time from randomization to first remission assessed by IRC or researchers.
Sponsors and contacts
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