None listed
Conditions
Interventions
Drug : Regimen) RD-RCHOP + Lenalidomide -->
Lenalidomide maintenance therapy
1)R-RDCHOP + ??????? (R2-RDCHOP)
: Rituximab 375 mg/m2 iv on day 1 + Cyclophosphamide 600 mg/m2 iv on day 1 + Doxorubicin 30 mg/m2 iv on day 1 + Vincristine fixed dos
Sponsors
Pusan National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologic subtypes as follows: CD20 positive Diffuse large B-Cell lymphoma 2. Age = 70 years old 3. Untreated patients. In patients with bulky mass or systemic symptoms or compressive or rapidly progressive disease, a pre-study treatment is allowed with steroids in the seven days prior the start of the study treatment. 4. Measurable and/or evaluable disease 5. Ann Arbor stage II, III, IV 6. International Prognostic Index at low-intermediate, intermediate-high, high risk (2/3/4-5) 7. Eastern Cooperative Oncology Group(ECOG) 0-1 8. Adequate hematological counts, kidney, liver, and cardiac function a. ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement b. Creatinine clearance = 50 mL / min (calculated by Cockcroft-Gault formula) c. ALT, AST = 2 x UNL, Total bilirubin = 2 x UNL d. Cardiac ejection fraction (MUGA scan or echocardiography) = 45% 9. Female patients who: a. Are naturally postmenopausal for at least 2 year before enrolment b. Are surgically sterile c. In the case of a pregnant woman, the pregnant woman must agree on the following: i. adhere to the lenalidomide pregnancy prevention risk management program in Appendix 6 ii. All women of childbearing potential must agree to have two negative pregnancy test within 10-14 days and 24hrs before commencing lenalidomide and use two reliable methods of contraception simultaneously or practice complete abstinence from any heterosexual intercourse during the following time periods related to this study: 1) for at least 28 days before starting study; 2) while participating in the study; 3) dose interruptions; and 4) for at least 28 days after study treatment discontinuation. The two methods of reliable contraception must include one highly effective method and one additional effective method to prevent pregnancy, not plan on conceiving children during or within 6 months following lenalidomide. (See Appendix E Pregnancy Prevention and Risk Management Program) 10. Male patients, even if surgically sterilized (i.e. status post-vasectomy), who: a. Agree to practice effective barrier contraception during the entire study treatment period and through 28 days after the last dose of study treatment b. Agree to completely abstain from heterosexual intercourse c. Must also adhere to the guidelines of the lenalidomide pregnancy prevention and risk management program
Exclusion criteria
Exclusion criteria: 1. Secondary malignant tumor within last 3 years. The following are exceptions: a. Properly treated squamous cell and basal cell carcinoma of the skin b. carcinoma in situ of the cervix c. Carcinoma In Situ of Breast undergoing total resection 2. Extensive radiation therapy, systemic chemotherapy, or other antineoplastic therapy before enrollment within 3 years before the start of treatment 3. Exposure to Rituximab prior to study entry 4. Known or suspected hypersensitivity or intolerance to Rituximab 5. Have received an experimental drug or used an experimental medical device within 4 weeks before the planned start of treatment. Concurrent participation in non-treatment studies is allowed, if it will not interfere with participation in this study. 6. CNS disease (meningeal and/or brain involvement by lymphoma), testicular involvement lymphoma 7. Uncontrolled or severe cardiovascular disease including myocardial infarction within 6 months of enrollment, New York Heart Association (NYHA) Class III or IV heart failure (Attachment 5, NYHA Classification of Cardiac Disease), uncontrolled angina, clinically significant pericardial disease, or cardiac amyloidosis 8. Active opportunistic infection 9. Patients with active B, C hepatitis and HIV 10. A patient with severe immunodeficiency 11. Patients with active severe infection 12. Pregnant women and possibly pregnant women 13. Patients with confirmed or suspected hypersensitivity to components of clinical trial medications, including lenalidomide 14. Because lenalidomide capsules contain lactose, they are administered to patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption Can not be done.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival;Overall survival rate;Complete remission rate;The overall response rate;Toxicity profiles;progression free survival period | — |
Countries
Korea, Republic of
Contacts
Public ContactDaesik Kim
Koera University Guro Hospital
Outcome results
None listed