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 (Jun 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
Treatments studied
Immunotherapy
Chemotherapy
Other
Cancer type
Diffuse Large B-Cell Lymphoma
Non-Hodgkin Lymphoma
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
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.
Frequently asked questions
Is NCT06792253 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior small molecule targeted drug therapy, , autologous hematopoietic stem cell transplantation disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify