OncoMatch/Clinical Trials/NCT06792253
Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Is NCT06792253 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments for relapsed/refractory diffuse large b-cell lymphoma.
Treatment: Ifupinostat Hydrochloride for · Rituximab · Gemcitabine Hydrochloride for · Oxaliplatin · Etoposide · Ifosfamide for · Carboplatin — 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).
Check if I qualifyExtracted eligibility criteria
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: systemic therapy including CD20 antibody
Must have relapsed or refractory diffuse large B-cell lymphoma after at least one systemic therapy [at least one systemic therapy must include CD20 antibody]
Cannot have received: small molecule targeted drug therapy
Received other small molecule targeted drug therapy within 2 weeks before enrollment
Cannot have received: (BEBT-908, R-ICE, R-GemOx)
Previously received BEBT-908 or R-ICE and R-GemOx therapy before enrollment
Cannot have received: autologous hematopoietic stem cell transplantation
Underwent autologous hematopoietic stem cell transplantation within 3 months before enrollment
Cannot have received: radiotherapy
Received radiotherapy that affects the evaluation of the efficacy of this study within 3 months before enrollment, or local supportive radiotherapy that affects the subject's bone marrow function
Cannot have received: myelosuppressive chemotherapy or biological therapy
Underwent myelosuppressive chemotherapy or biological therapy within 3 weeks before enrollment
Cannot have received: traditional Chinese medicine and patent medicine with antitumor effects
Used traditional Chinese medicine and patent medicine with antitumor effects within 2 weeks before enrollment
Cannot have received: major surgery
Exception: tumor biopsy allowed
Underwent major surgery ... other than tumor biopsy within 4 weeks before enrollment, or the side effects of the surgery have not yet stabilized
Cannot have received: hematopoietic cell colony-stimulating factor therapy (G-CSF, GM-CSF, TPO)
Exception: Subjects who have started receiving erythropoiesis-stimulating agents or darbepoetin within 2 weeks prior to enrollment are eligible for inclusion.
Received any hematopoietic cell colony-stimulating factor therapy (such as granulocyte colony-stimulating factor G-CSF, granulocyte-macrophage colony-stimulating factor GM-CSF) or thrombopoietin TPO therapy ... within 2 weeks before enrollment
Cannot have received: glucocorticoids (prednisone)
Exception: If used for the treatment of diseases other than lymphoma ... up to 10 mg per day of prednisone (or equivalent dose of other glucocorticoids) allowed
Received prednisone >10mg per day (or other equivalent doses of glucocorticoids) within 7 days before enrollment
Cannot have received: CAR-T cell immunotherapy
Underwent chimeric antigen receptor T cell immunotherapy (CAR-T therapy) within 3 months before enrollment
Lab requirements
Blood counts
ANC ≥1.0×10^9/L; HGB ≥80g/L; PLT ≥100×10^9/L
Kidney function
Serum creatinine <1.5×ULN
Liver function
Serum total bilirubin ≤1.5×ULN (for patients with Gilbert syndrome, total bilirubin <3.0×ULN with direct bilirubin within normal range); ALT, AST ≤2.5×ULN (≤5×ULN if there is liver involvement)
Cardiac function
LVEF <50% (MUGA or ECHO); QTcF >450ms for males and >470ms for females; unstable angina; symptomatic pericarditis; myocardial infarction within past 6 months with persistent elevation of cardiac enzymes or persistent regional left ventricular wall abnormalities; history of congestive heart failure (NYHA Class III-IV), or history of cardiomyopathy
Organ function levels must meet the following requirements: Peripheral blood: ANC ≥1.0×10^9/L; HGB ≥80g/L; PLT ≥100×10^9/L; Liver and kidney function: Serum total bilirubin ≤1.5×ULN (for patients with Gilbert syndrome, total bilirubin <3.0×ULN with direct bilirubin within normal range); Serum creatinine <1.5×ULN; ALT, AST ≤2.5×ULN (≤5×ULN if there is liver involvement). Cardiac: LVEF <50% (MUGA or ECHO); QTcF >450ms for males and >470ms for females; unstable angina; symptomatic pericarditis; myocardial infarction within past 6 months with persistent elevation of cardiac enzymes or persistent regional left ventricular wall abnormalities; history of congestive heart failure (NYHA Class III-IV), or history of cardiomyopathy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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