Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeBetter Med Inc
About this trial
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 criteria
Qualifiers
The subject has been fully informed and is willing to sign the Informed Consent Form (ICF).
Age is ≥18 years and ≤75 years, both men and women are eligible.
Pathologically diagnosed as diffuse large B-cell lymphoma according to the 2022 World Health Organization classification, confirmed by central pathology review (Patients who relapse after more than one year need to undergo tissue biopsy again to confirm the pathological diagnosis.).
Measurable lesions [The criteria for measurable lesions are: the longest diameter of lymph node lesions measured by enhanced Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) is greater than 15 mm, and the longest diameter of extranodal lesions is greater than 10 mm.] assessed by Positron Emission Tomography/Computed Tomography (PET-CT) and Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) according to the Lugano 2014 criteria .
Disqualifiers
Known severe allergy to the study drug or any of its excipients;
Men and women who have not undergone in vitro preservation of sperm or oocytes and plan to have children within 5 years, unless subsequent studies confirm reproductive safety;
Pregnant or breastfeeding women;
Primary central nervous system lymphoma;
Trial design
Treatments tested in this trial
- Ifupinostat Hydrochloride for Injection
- Rituximab Injection
- Gemcitabine Hydrochloride for Injection
- Oxaliplatin Injection
- Etoposide Injection
- Ifosfamide for Injection
- Carboplatin Injection
Treatment groups
416 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov