Actively Recruiting

Phase 3
Age: 18Years - 75Years
All Genders
NCT06792253

Study Comparing BEBT-908 Combined With R to SOC for the Treatment of 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

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).

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

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Research Team

K

Kegang Jiang, Master

CONTACT

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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