Actively Recruiting
Phase III Trial Comparing BEBT-908 Plus Rituximab to Standard Chemotherapy for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Led by BeBetter Med Inc · Updated on 2025-01-24
416
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a multicenter, randomized, controlled, open-label Phase III clinical trial to evaluate the effectiveness and safety of BEBT-908 combined with rituximab compared to standard chemotherapy regimens for treating relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). The study aims to compare this new combination treatment with investigator-selected standard chemotherapy options, including rituximab-gemcitabine-oxaliplatin (R-GemOx) or rituximab-ifosfamide-carboplatin-etoposide (R-ICE). A total of 416 participants will be randomly assigned in equal numbers to either the experimental group receiving BEBT-908 plus rituximab or the control group receiving the standard chemotherapy regimen chosen by their investigator. Treatment cycles last 21 days, with 8 cycles planned. The experimental group will receive BEBT-908 and rituximab during these cycles and may continue with a maintenance phase up to 24 months if their disease does not progress after cycle 8. The control group will receive their assigned chemotherapy for 8 cycles without further study medication afterward. Participants will go through screening lasting up to 21 days, followed by treatment and post-treatment follow-up phases. Tumor assessments occur every 6 weeks during the first 8 cycles and every 9 weeks thereafter. After treatment ends, safety follow-up happens 28 days after the last dose, efficacy follow-up every 9 weeks, and survival follow-up every 3 months. The main outcome measured is overall survival up to 48 months.
CONDITIONS
Official Title
Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fully informed and willing to sign the Informed Consent Form
- Aged between 18 and 75 years, any gender
- Pathologically confirmed diffuse large B-cell lymphoma per 2022 WHO classification, confirmed by central review
- Measurable lesions per imaging criteria assessed by PET-CT and CT or MRI
- Relapsed or refractory DLBCL after at least one systemic therapy including CD20 antibody
- ECOG performance status score between 0 and 2
- Expected survival longer than 12 weeks
- Adequate organ function: ANC ≥1.0 x10^9/L, hemoglobin ≥80 g/L, platelets ≥100 x10^9/L; bilirubin ≤1.5x ULN (≤3.0x ULN with normal direct bilirubin for Gilbert syndrome); creatinine <1.5x ULN; ALT and AST ≤2.5x ULN (≤5x ULN if liver involvement)
You will not qualify if you...
- Known severe allergy to study drug or its components
- Men and women planning children within 5 years without sperm/oocyte preservation
- Pregnant or breastfeeding women
- Primary central nervous system lymphoma
- DLBCL with active CNS brain metastases or meningeal involvement
- Other active cancers requiring treatment that may interfere with study
- Recent prior treatments: small molecule targeted therapy within 2 weeks; prior BEBT-908 or R-ICE/R-GemOx therapy; autologous stem cell transplant within 3 months; radiotherapy affecting efficacy evaluation within 3 months; myelosuppressive chemo or biological therapy within 3 weeks; antitumor traditional Chinese medicine within 2 weeks; major surgery within 4 weeks or unstable surgery side effects; hematopoietic growth factor therapy within 2 weeks except for certain agents; prednisone >10 mg/day within 7 days unless for certain conditions at stable dose; CAR-T therapy within 3 months
- Persistent grade 2 or higher toxicities from prior treatment not stabilized
- Active severe infection grade 2 or higher
- Poorly controlled diabetes, severe pulmonary or cardiac disease, significant renal/hepatic dysfunction
- Uncontrolled active hepatitis B, C, syphilis, or active Epstein-Barr virus infection
- Known HIV positive
- History or presence of severe mental illness or mood disorders
- Need for anticoagulant or antiplatelet therapy during study
- Uncontrolled hypertension (≥180/110 mmHg)
- Severe medical conditions with bleeding risk or history
- Use of drugs causing QT prolongation
- Strong CYP3A4 inhibitors or inducers within 4 weeks or during study
- Participation in other clinical trials with investigational drugs within 4 weeks
- Any unstable condition compromising safety or compliance
- Investigator judgment deeming subject unsuitable for protocol treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
Cancer Hospital Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
K
Kegang Jiang, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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