BridgeMD
Compares treatment options for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Official title Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
ClinicalTrials.gov ID: NCT06792253
What this study is testing
What is Ifupinostat Hydrochloride for Injection?
Ifupinostat Hydrochloride for Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for relapsed/refractory diffuse large b-cell lymphoma.
Also referred to as BEBT-908 for Injection, CUDC-908.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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...
- Measurable lesions [The criteria for measurable lesions are: the longest diameter of lymph node lesions measured by enhanced Computed Tomography (CT)...
- Must have relapsed or refractory diffuse large B-cell lymphoma after at least one systemic therapy [Salvage chemotherapy and immunotherapy after stem...
You likely can't join 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 people 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...
- 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;
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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).
What rules you out
- 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 people 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 how well it works 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...
- 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 (people who...
- 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...
- 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...
- 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) \ 450ms for males and \> 470ms for females (QTcF formula); unstable angina; symptomatic pericarditis; myocardial...
- Significant renal or hepatic dysfunction;
- Uncontrolled active hepatitis B, hepatitis C, syphilis (individuals with both specific and non-specific syphilis antibodies positive), and active Epstein-Barr virus infection [The following active infections with...
- Known positive for human immunodeficiency virus (HIV);
- History of mental illness, family history of mental illness, or mood disorders as judged by the investigator or psychiatrist [Including a medical history of depressive episodes, bipolar disorder (Type I or II)...
- Need for concomitant anticoagulant or antiplatelet therapy during the study period;
- Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg);
- Severe internal medical conditions with a risk of major bleeding or a history of major bleeding.
- Concurrent use of drugs that may cause QT interval prolongation or torsades de pointes;
- Within 4 weeks prior to enrollment, currently receiving or requiring treatment with strong inhibitors or inducers of cytochrome P450 (CYP) 3A4 isoenzyme after enrollment (Within 4 weeks prior to enrollment and during...
- Within 4 weeks prior to enrollment, participated in other clinical trials and used investigational drugs;
- Any unstable condition or situation that may jeopardize the subject's safety and compliance with the study as judged by the investigator;
- people deemed unsuitable for treatment with this protocol by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.