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
BeBetter Med Inc
416 participants
Jan 6, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
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.
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.
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.
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.
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.
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06792253