None listed
Conditions
Interventions
Drug : During each phase, all participants who meet the eligibility criteria and complete pre-treatment assessments during a 6-week screening period will receive pomalidomide-R-CHOP therapy for up to
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 19 years or older (If aged 80 years or older, enrollment is allowed at the investigator’s discretion if the ECOG Performance Status (PS) is 0-1 and the Cumulative Illness Rating Scale (CIRS) score for each organ system is = 2 regarding comorbidities.) 2. Individuals who understand the informed consent form and voluntarily sign the written consent. 3. Individuals who can comply with the clinical trial visit schedule and other protocol requirements. 4. Patients with histologically confirmed CD20+ DLBCL. 5. Patients with no prior history of treatment for DLBCL. 6. Patients classified as high risk for CNS relapse, meeting at least one of the following criteria: d. CNS-IPI score of 4 or higher. e. Presence of at least one high-risk site for CNS relapse, such as the testis, breast, adrenal gland, kidney, nasal cavity, or paranasal sinuses. f. Double-hit lymphoma, characterized by MYC rearrangement along with BCL2 or BCL6 rearrangement. 7. ECOG performance status of 0 or 1. 8. Patients with hematologic status and major organ function meeting the following criteria: a. Absolute neutrophil count (ANC) = 1,500 cells/mm³ (1.5 x 10?/L) (= 1,000 cells/mm³ in cases of secondary reduction due to bone marrow or spleen involvement by lymphoma) b. Platelet count = 75,000/mm³ (75 x 10?/L) (= 50,000/mm³ in cases of secondary reduction due to bone marrow or spleen involvement by lymphoma) c. Hemoglobin = 7.5 g/dL (4.7 mmol/L) d. Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 3.0 x upper limit of normal (ULN) (= 5.0 x ULN in cases of liver involvement by lymphoma) e. Serum total bilirubin = 2.0 mg/dL (34 µmol/L) (= 5.0 mg/dL in cases of Gilbert's syndrome or liver/pancreatic involvement by lymphoma) f. Calculated creatinine clearance (Cockcroft-Gault formula) = 30 mL/min g. White blood cell (WBC) count = 3.0 x 10³/µL 9. Patients who are HBsAg positive may be enrolled if HBV DNA is < 500 IU/mL, they have been on antiviral therapy for at least two weeks before the start of treatment, and they agree to follow antiviral treatment guidelines during the clinical trial. Patients who are HBsAg negative but HBcIgG Ab positive may be enrolled if they undergo prophylactic antiviral therapy. 10. Patients with inactive hepatitis C (normal aminotransferase levels and undetectable serum HCV RNA) are eligible. 11. Female patients of childbearing potential must meet the following criteria: a. Have a negative pregnancy test result prior to trial participation. These women must agree to ongoing pregnancy testing throughout the trial and after trial therapy, even if practicing complete abstinence from heterosexual intercourse. b. Agree to practice complete abstinence from heterosexual intercourse (reviewed monthly) or use continuous effective contraception from 28 days prior to the start of trial therapy, throughout the trial (including during treatment interruptions), and for up to 12 months after discontinuation of therapy. 12. Male patients must meet the following criteria: a. Even if they have had a successful vasectomy, they must agree to practice complete abstinence or use condoms when engaging in sexual intercourse with a pregnant woman or a woman of childbearing potential during the trial, throughout any treatment interruptions, and for at least 28 days after discontinuation of the investigational drug. b. Agree not to donate sperm during the
Exclusion criteria
Exclusion criteria: 1. The following subtypes of 5th WHO classification of large B-cell lymphoma: a. T-cell/histiocyte-rich large B-cell lymphoma b. ALK-positive large B-cell lymphoma c. Lymphomatoid granulomatosis d. Primary effusion large B-cell lymphoma e. Plasmablastic lymphoma f. Primary cutaneous diffuse large B-cell lymphoma, leg type g. Primary mediastinal (thymic) large B-cell lymphoma h. Intravascular large B-cell lymphoma i. Primary mediastinal large B-cell lymphoma j. Mediastinal grey zone lymphoma 2. Post-transplant lymphoproliferative disorder (PTLD) 3. History of diseases other than DLBCL, evidence of composite DLBCL and follicular lymphoma, or evidence of transformed non-Hodgkin lymphoma 4. Prior immunotherapy or chemotherapy for DLBCL, except for short-term corticosteroids (= 10 days) 5. Central nervous system involvement confirmed by imaging or cerebrospinal fluid cytology 6. Contraindications to any drugs included in the chemotherapy, specifically: a. Left ventricular ejection fraction 200 mg/m² 7. Positive HIV serology 8. Untreated HBV infection 9. Active HCV infection 10. Diagnosis of other malignancies within the past five years, excluding completely cured basal cell carcinoma of the skin, non-metastatic cervical carcinoma, papillary thyroid cancer, and early-stage gastric cancer 11. Major surgery within 28 days prior to enrollment (excluding lymph node or bone marrow biopsy) 12. Use of standard or experimental anticancer therapy within 28 days prior to the first dose of the investigational drug 13. Prior use of lenalidomide or pomalidomide 14. Known Grade 2 or higher allergic or hypersensitivity reactions to thalidomide, lenalidomide, or pomalidomide 15. Known sensitivity or allergy to murine-derived products 16. Individuals with genetic disorders such as galactose intolerance (e.g., angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis) or glucose-galactose malabsorption 17. Individuals unwilling to receive prophylactic venous thrombosis prevention therapy 18. Other severe diseases or medical conditions, including: a. Unstable heart disease despite treatment b. History of myocardial infarction or unstable angina within three months prior to enrollment c. Significant neurological or psychiatric disorders, including dementia or epilepsy d. Uncontrolled hypertension (systolic blood pressure > 180 mmHg at screening) e. Uncontrolled clinically significant active hepatitis f. Other severe medical conditions 19. Pregnant or breastfeeding women 20. Uncontrolled comorbid conditions 21. Any significant medical condition, abnormal laboratory finding, or psychiatric illness that could interfere with the ability to provide informed consent 22. Severe active infection or abnormal laboratory findings that would pose unacceptable risks for trial participation 23. Any condition that could interfere with the interpretation of data obtained from the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-Limiting Toxicity (DLT) Incidence, Maximum Tolerated Dose (MTD) | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete Response Rate (CRR), Overall Response Rate (ORR), Progression-Free Survival (PFS);Overall Survival (OS);6-month cumulative CNS relapse rate;Analysis of the correlation between cerebrospinal fluid ctDNA concentration and efficacy variables.;Compare blood and cerebrospinal fluid ctDNA profiles and analyze the correlation with CNS relapse.;Evaluation of immune cell profiles through PBMC flow cytometry. | — |
Countries
Korea, Republic of
Contacts
Public ContactNa Eun Lee
Asan Medical Center
Outcome results
None listed