Status and phase
Conditions
Treatments
About
Oral Lenalidomide is initiated on day 1 of cycle 1 at the dose of 20 mg daily for 21 days with 7 days rest (28 day cycle) for a total of 4 cycles. Rituximab is administered on day 1 and day 21 of each cycle at the dose of 375 mg/m2 for a total of 4 cycles.
After this induction phase, the CR, PR and SD will continue Lenalidomide with the same schedule for other 8 months.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Understand and voluntarily sign an informed consent form.
Be = 65 years of age at the time of signing the informed consent form.
Able to adhere to the study visit schedule and other protocol requirements.
Patients with histological confirmation of DLBCL.
Stage of disease at study entry may include stage II-III-IV according to Ann Arbor Classification
Patients must have failed at least one prior treatments
ECOG performance status of equal or less than 2 at study entry
nLaboratory test results within these ranges:
Absolute neutrophil count equal or major than 1.0 x 109/L
Platelet count equal or major than 50 x 109/L
Serum creatinine equal or less than 2.0 mg/dL
Total bilirubin equal or less than 1.5 mg/dL
AST (SGOT) and ALT (SGPT) equal or less than 2 x ULN or equal or less 5 x ULN if hepatic metastases are present
Hemoglobin equal or major than 8 g/dl
Females of childbearing potential (FCBP) must agree to use two reliable forms of contraception simultaneously or to practice complete abstinence from heterosexual intercourse during the following time periods related to this study:
Disease free of prior malignancies for equal or major 5 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma "insitu" of the cervix or breast
Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation. (patients intolerant to ASA may use warfarin or low molecular weight heparin).
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
25 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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