Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Recruiting now · Phase 3

Conditions studied: Relapsed/Refractory Diffuse Large B-Cell Lymphoma

In brief

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).

Key facts

Study ID: NCT06792253
Run by: BeBetter Med Inc
People needed: 416
Starts: 2025-01-06
Expected to finish: 2029-06-30
Last updated by the study team: 2025-01-24

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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 .
Must have relapsed or refractory diffuse large B-cell lymphoma after at least one systemic therapy [Salvage chemotherapy and immunotherapy after stem cell transplantation will be considered as first-line systemic treatment; maintenance therapy will not be counted as a separate line of systemic treatment; local radiotherapy for diffuse large B-cell lymphoma (DLBCL) aimed at cure will not be counted as first-line systemic treatment; patients who do not achieve PR after four cycles of first-line treatment are eligible for the study; patients who do not achieve PR after two cycles of second-line or higher treatment are eligible for the study. Primary refractory DLBCL patients are defined as those who have no response during first-line treatment or relapse within six months after the end of treatment, and they will be allowed to participate in the study. Patients who relapse within 12 months after stem cell transplantation are also eligible for inclusion. Refractory DLBCL patients are those who do not achieve response after adequate front-line treatment (at least four cycles of first-line chemotherapy, or at least two cycles of subsequent treatment), or who progress during previous first-line treatment, or who progress within six months (less than six months) after achieving response to previous adequate front-line treatment, or who relapse within 12 months after achieving response to stem cell transplantation. Relapsed DLBCL patients are those who relapse six months or more after achieving response to previous adequate front-line treatment, or who relapse 12 months or more after achieving response to stem cell transplantation.], and at least one systemic therapy must include CD20 antibody.
Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
Expected survival >12 weeks.
Organ function levels must meet the following requirements:
Peripheral blood:
Absolute neutrophil count (ANC) ≥1.0×10\^9/L;
Hemoglobin (HGB) ≥80g/L;
Platelet count (PLT) ≥100×10\^9/L;
Liver and kidney function:
Serum total bilirubin ≤1.5×Upper Limit of Normal (ULN) (for patients with Gilbert syndrome, total bilirubin <3.0×ULN with direct bilirubin within normal range);
Serum creatinine <1.5×ULN;
Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) ≤2.5×ULN (≤5×ULN if there is liver involvement).

You may not qualify if…

Known severe allergy to the study drug or any of its excipients;
Due to the potential genotoxicity, mutagenicity, and teratogenicity of the study drug, the following subjects should be excluded:
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;
DLBCL with active central nervous system brain metastases or meningeal involvement at the time of screening;
Other active malignant tumors that require treatment and may interfere with the study.
Treatment history before the trial:
Received other small molecule targeted drug therapy within 2 weeks before enrollment;
Previously received BEBT-908 or R-ICE and R-GemOx therapy before enrollment;
Underwent autologous hematopoietic stem cell transplantation within 3 months before enrollment;
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;
Underwent myelosuppressive chemotherapy or biological therapy within 3 weeks before enrollment;
Used traditional Chinese medicine and patent medicine with antitumor effects within 2 weeks before enrollment;
Underwent major surgery (Referring to the Level 3 and Level 4 surgeries as stipulated in the "Administrative Measures for the Clinical Application of Medical Technologies" implemented on May 1, 2009.) other than tumor biopsy within 4 weeks before enrollment, or the side effects of the surgery have not yet stabilized;
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 (Subjects who have started receiving erythropoiesis-stimulating agents or darbepoetin within 2 weeks prior to enrollment are eligible for inclusion.) within 2 weeks before enrollment;
Received prednisone >10mg per day (or other equivalent doses of glucocorticoids) within 7 days before enrollment [If used for the treatment of diseases other than lymphoma, such as rheumatoid arthritis, polymyalgia rheumatica, adrenal insufficiency, or asthma, subjects may receive a stable dose of up to 10 mg per day of prednisone (or an equivalent dose of other glucocorticoids).];
Underwent chimeric antigen receptor T cell immunotherapy (CAR-T therapy) within 3 months before enrollment.
After the previous treatment (chemotherapy or biological therapy), there are persistent Grade 2 or higher [Common Terminology Criteria for Adverse Events (CTCAE) V5.0 criteria] toxicities that have not stabilized at the time of enrollment (alopecia excluded);
There is an active clinical severe infection of Grade 2 or higher (CTCAE V5.0 criteria);
Co-morbid conditions:
Poorly controlled diabetes mellitus [with a random blood glucose level ≥11.1 mmol/L or Glycosylated Hemoglobin, Type A1C (HbA1c) ≥8.5% despite hypoglycemic treatment];
Severe pulmonary disease (CTCAE V5.0 Grade III-IV);
Severe cardiac disease [Including any of the following: left ventricular ejection fraction (LVEF) <50% detected by cardiac radionuclide scan [Multigated Acquisition (MUGA)] or echocardiogram (ECHO); Fridericia-corrected QT value (QTcF interval) >450ms for males and > 470ms for females (QTcF formula); unstable angina; symptomatic pericarditis; myocardial infarction within the past 6 months with persistent elevation of cardiac enzymes or persistent regional left ventricular wall abnormalities recorded during LVEF measurement; history of congestive heart failure (New York Heart Association Class III-IV), or history of cardiomyopathy.].
Significant renal or hepatic dysfunction;

Where it is running

Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.