None listed
Conditions
Interventions
Drug : Golcamide 0.4 mg is administered once daily for 14 consecutive days over 18 cycles, each cycle lasting 28 days. Rituximab is administered intravenously once daily at a dose of 375 mg/m² on days
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 19 years or older (at the time of signing the written informed consent form [ICF]) 2) Must understand the study content and voluntarily sign the consent form before any study-related evaluations or procedures are performed. 3) Must have the willingness and ability to comply with visit schedules and protocol requirements. 4) Individuals diagnosed with histologically confirmed aggressive large B-cell lymphoma (DLBCL) according to the 2022 WHO classification: A. DLBCL, NOS (including GCB and ABC subtypes) B. DLBCL/high-grade B-cell lymphoma with MYC and BCL2 rearrangements C. High-grade B-cell lymphoma, NOS D. T-cell/histiocyte-rich large B-cell lymphoma E. EBV-positive DLBCL 5) Relaspe/refractory disease after at least one prior line of therapy (including anthracycline-based therapy), where hematopoietic stem cell transplantation is not indicated or is unsuitable 6) For FDG-avid subtypes according to the Lugano classification, at least one lesion with FDG uptake must be present, and the lesion must be two-dimensionally measurable (long axis > 1.5 cm) on CT or MRI 7) ECOG performance status must be 0, 1, or 2 8) The following laboratory criteria must be met: A. ANC = 1.0 × 10?/L; however, = 0.5 × 10?/L is permitted if bone marrow involvement is due to hypersplenism associated with DLBCL. G-CSF administration is prohibited 7 days prior to screening (14 days prior for pegfilgrastim). B. Hemoglobin = 75 g/L (7.5 g/dL) — Transfusion permitted if lymphoma involves the bone marrow; screening must be performed at least 1 week after transfusion. C. Platelet count = 75 × 10?/L; however, = 50 × 10?/L if splenomegaly related to DLBCL is present, requiring 7 days without transfusion. D. AST/ALT = 2.5 × ULN, except = 5 × ULN if liver involvement. E. Total bilirubin = 1.5 × ULN, except = 3 × ULN if liver involvement. F. Estimated CrCL = 30 mL/min G. INR < 1.5 × ULN and aPTT < 1.5 × ULN (if not receiving anticoagulant therapy). However, subjects undergoing treatment for thromboembolism within 3 months prior to enrollment may be included if they are on stable anticoagulant therapy (e.g., warfarin, low molecular weight heparin). 9) For women of childbearing potential (IOCBP): A. Two negative pregnancy tests are required prior to study drug administration, and ongoing pregnancy testing must be performed during the study and after treatment completion. This applies even if the subject practices true abstinence from heterosexual contact. B. From 28 days before study start until 28 days after the last golcamidomide dose, or 12 months after rituximab and pazopanib dosing, whichever is longer, subjects must maintain absolute abstinence or use one highly effective contraceptive method plus one additional barrier method. Note: IOCBP refers to individuals meeting any one of the following criteria: (1) Has experienced menarche, (2) Has not undergone hysterectomy with bilateral salpingo-oophorectomy, (3) Has been in natural menopause for less than 12 months for non-medical reasons. 10) Female subjects must agree to refrain from egg donation during study treatment and for at least 28 days after the last dose of golcadomide. 11) Male subjects must meet the following: A. Maintain true abstinence during the study (including drug-free periods) and for the longer of 28 days after the last dose of golcamidomide, 90 days after rituximab, or 12 months after pazopanib. If pregnant or having sexual intercourse with a woman of childbearing potential, condom use is requi
Exclusion criteria
Exclusion criteria: 1.Subjects who have previously received golcamid treatment. 2.Subjects who have previously received BTK inhibitor treatment. 3.The subject's life expectancy is less than 2 months. 4.If the subject has received any of the following: A. Major surgery (as defined by the investigator) within 28 days of starting the clinical trial treatment (the subject must have recovered from any clinically significant effects of the recent surgery) B. Radiation therapy within 28 days prior to starting the clinical trial treatment. C. Use of any systemic anticancer therapy (approved or investigational) within 28 days or 5 half-lives prior to starting the clinical trial treatment, whichever is shorter. (Participation in another interventional clinical trial concurrently with this trial is not permitted, except for subjects who completed treatment with a prior investigational drug and are currently in long-term follow-up). 5.Previously received a solid organ transplant 6.Received allogeneic SCT within 1 year prior to starting the clinical trial treatment or received autologous SCT within 3 months prior to starting the clinical trial treatment. A. Subjects with prior SCT must not have Grade 1 or higher treatment-related toxicity. B. Subjects with prior SCT must not have clinically significant active graft-versus-host disease (GVHD). 7. Subjects with other lymphoma subtypes (excluding primary mediastinal [thymic] large B-cell lymphoma, primary cutaneous DLBCL-leg type, grade 3b FL, ALK-positive large B-cell lymphoma, primary effusion lymphoma, or Burkitt lymphoma) 8.Subjects with central nervous system (CNS) involvement due to lymphoma. 9.Subjects with serious medical conditions, including active or uncontrolled infections, laboratory abnormalities, or psychiatric disorders (e.g., uncontrolled diabetes, uncontrolled hypertension), that would place them at unacceptable risk for treatment-related complications if they participate in the study. 10.Subjects with conditions that would confound interpretation of study data. 11.Persistent diarrhea or malabsorption of Grade 2 or higher despite medical management 12. History of malignant tumors other than lymphoma (except if the participant has been free of the disease for at least 3 years). Exceptions to the 3-year period restriction include the following history: A. Localized non-melanoma skin cancer B. Primary cervical carcinoma C. In situ carcinoma of the breast D. Prostate cancer (T1a or T1b according to the Tumor Node Metastasis staging system) or incidental histologic findings of prostate cancer treated for therapeutic purposes 13. If you have had cardiac dysfunction defined by any of the following or clinically significant cardiovascular disease within 6 months prior to enrollment: A. Acute myocardial infarction or acute coronary syndrome (e.g., unstable angina, coronary artery bypass grafting, coronary angioplasty or stenting, symptomatic pericardial effusion) B. Clinically significant cardiac arrhythmia (e.g., uncontrolled atrial fibrillation, uncontrolled paroxysmal supraventricular tachycardia, sustained ventricular arrhythmia) C. Long QT syndrome (or QTcF = 470msec on screening ECG) D. Left ventricular ejection fraction (LVEF) <45% (as determined by multigated acquisition scan (MUGA) or echocardiogram (ECHO)) E. Complete left bundle branch block or bilateral block 14.Concomitant administration of potent CYP3A4/5 modulators. The withdrawal period for potent CYP3A4/5 modulators is the longer of 7 days prior
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the tolerability and safety of golcamide and rituximab with poseltinib and define the recommended Phase 2 dose of poseltinib. | — |
Secondary
| Measure | Time frame |
|---|---|
| The efficacy of the combination therapy of poseltinib, golcadomide, and rituximab is evaluated based on ORR according to the Lugano criteria | — |
Countries
Korea, Republic of
Contacts
Public ContactJamin Byun
Seoul National University Hospital
Outcome results
None listed