Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Kegang Jiang, Master
CONTACT
Lead
BeBetter Med Inc
The study will recruit 416 subjects, who will be randomly assigned in a 1:1 ratio to either the experimental group (BEBT-908 combined with R) or the control group \[investigator-selected standard chemotherapy regimen (R-GemOx or R-ICE)\]. Approximately 208 subjects will be enrolled in the experimental group, and approximately 208 in the control group. The treatment cycle is 21 days, with a total of 8 treatment cycles. The experimental group will receive BEBT-908 + R treatment from cycles 1 to 8; participants who do not appear progressive disease (PD) after cycle 8 may continue to receive BEBT-908 and/or R treatment, entering a maintenance phase of up to 24 months. The control group will receive the investigator-selected SOC (i.e., R-GemOx or R-ICE) treatment from cycles 1 to 8, and will not receive further study medication after cycle 8. Each subject's study process includes three phases: screening, treatment, and post-treatment follow-up. The screening phase can last up to 21 days. During the treatment phase, tumor assessments will be conducted every 6 weeks (±7 days) within the first 8 treatment cycles, and every 9 weeks (±7 days) after cycle 8.After the end of treatment, safety follow-up will be conducted on day 28 (+7 days) after the last dose, efficacy follow-up will be conducted every 9 weeks (±7 days), and survival follow-up will be conducted every 3 months (±2 weeks).
Age
18–75
Sex
ALL
Healthy volunteers
Not accepted
