NCT06792253

Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Phase Ⅲ Clinical Trial Comparing BEBT-908 Combined With Rituximab (R) to Standard of Care for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 416 (estimated)
• Sponsor: BeBetter Med Inc · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, controlled, open-label Phase III clinical trial, aimed at evaluating the efficacy and safety of BEBT-908 combined with rituximab (R) compared to investigator-selected standard chemotherapy regimens \[Standard of Care (SOC)\] \[i.e., rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE)\] for the treatment of relapsed/refractory diffuse large B-cell lymphoma (r/r DLBCL).

Detailed description

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).

Conditions

• Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Ifupinostat Hydrochloride for Injection	Ifupinostat Hydrochloride for Injection,dosage of administration:18.5mg/m\^2,frequency and duration of administration:Medication is administered on days 1, 3, 5, 8, 10, and 12 of each cycle,with a 21-day or 42-day cycle duration.
DRUG	Rituximab Injection	Rituximab Injection,dosage of administration:375 mg/m\^2,frequency and duration of administration:Medication is administered on day 1 of each cycle or every third cycle, with a 21-day cycle duration.
DRUG	Gemcitabine Hydrochloride for Injection	Gemcitabine Hydrochloride for Injection,dosage of administration:1g/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.
DRUG	Oxaliplatin Injection	Oxaliplatin Injection,dosage of administration:100mg/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.
DRUG	Etoposide Injection	Etoposide Injection,dosage of administration:100mg/m\^2,frequency and duration of administration:Medication is administered on days 1,2,and 3 of each cycle, with a 21-day cycle duration.
DRUG	Ifosfamide for Injection	Ifosfamide for Injection,dosage of administration:5000mg/m\^2,frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.
DRUG	Carboplatin Injection	Carboplatin Injection,,dosage of administration:single dose ≤800 mg (calculated based on AUC=5),frequency and duration of administration:Medication is administered on day 2 of each cycle, with a 21-day cycle duration.

Timeline

• Start date: 2025-01-06
• Primary completion: 2028-12-31
• Completion: 2029-06-30
• First posted: 2025-01-24
• Last updated: 2025-01-24

Locations

1 site across 1 country: China