RecruitingPhase 3NCT06792253

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


Sponsor

BeBetter Med Inc

Enrollment

416 participants

Start Date

Jan 6, 2025

Study Type

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study compares a new drug combination — BEBT-908 plus rituximab — against the current standard treatment for people with diffuse large B-cell lymphoma (a type of blood cancer) that has come back or stopped responding to prior therapy. **You may be eligible if...** - You are 18–75 years old with confirmed diffuse large B-cell lymphoma - Your lymphoma has relapsed or not responded to at least one prior treatment - Your cancer can be measured on scans - Your organ function is adequate **You may NOT be eligible if...** - You have had more than two prior treatments for this lymphoma - You have serious uncontrolled infections or significant organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIfupinostat 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.

DRUGRituximab 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.

DRUGGemcitabine 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.

DRUGOxaliplatin 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.

DRUGEtoposide 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.

DRUGIfosfamide 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.

DRUGCarboplatin 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.


Locations(1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06792253


Related Trials