Relapsed or Refractory Diffuse Large B-cell Lymphoma Clinical Trial
Official title:
An Open, Multicenter Phase II Study of the Efficacy and Safety of BEBT-908 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
This is an open,single-arm,multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: phase Ⅱa and phase Ⅱb. Phase Ⅱa is an exploratory study, which mainly explores the safe and effective dose and the relationship between gene and protein markers and drug sensitivity. The main purpose of the phase Ⅱb study was to evaluate the Objective response rate of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma, and the secondary study was to evaluate the disease control rate, progression-free survival, time to response, duration of response, overall survival and safety tolerance of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The relationship between the biomarkers of BEBT-908 for injection and the efficacy and safety was evaluated.
This is an open, single-arm, multicenter phase II clinical study to evaluate the efficacy and safety of BEBT-908 for injection in the treatment of relapsed or refractory diffuse large B-cell lymphoma. The study will be divided into two stages: Ⅱa and Ⅱb, stage Ⅱa is an exploratory study, which mainly explores the safe and effective dose, 30 cases are planned to be included in the group, stage Ⅱb mainly evaluates the efficacy and safety of BEBT-908 for injection, according to the preliminary overall efficacy analysis of stage Ⅱa, the sample size of stage Ⅱb is about 90 cases. In phase Ⅱa and Ⅱb study, the initial dose was 22.5mg/m2, intravenous drip, 21 days as a cycle and 6 cycles as the total treatment cycle. The drugs were given on the 1st, 3rd, 5th, 8th, 10th and 12th day of each cycle. The study process of each subject included three periods: screening period, treatment period and follow-up period after treatment. During the treatment period, all safety items were examined before administration on the first day of each cycle, and the tumor was evaluated every 2 cycles. After the termination of treatment, the subjects will enter the follow-up period. Receive curative effect follow-up every 6 weeks (to tumor progression or other anti-tumor therapy) and survival follow-up every 3 months. ;
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