patient with BDLCL elderly untreated MedDRA version: 6.1 Level: PT Classification code 10012825
Conditions
Interventions
Product Name: Lenalidomide
Product Code: CC-5013
Pharmaceutical Form: Capsule, hard
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Trade Name: MABTHERA
Pharmac
Sponsors
GIMURELL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Histologic subtypes as follows: a. CD20 positive Diffuse large B-Cell lymphoma b. CD20 positive Follicular grade IIIb 2. Age 60-80 3. Measurable and/or evaluable disease. 4. Ann Arbor stage II, III, IV 5. International Prognostic Index at low-intermediate, intermediate, high risk (2/3/4-5) 5. Adequate haematological counts: ANC > 1.5 x 109/L and platelet count > 75 x 109/L unless due to bone marrow involvement 6. Conjugated bilirubin up to 2 x ULN. 7. Alkaline phosphatase and transaminases up to 2 x ULN. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Lymphoblastic Lymphoma 2. Burkitt Lymphoma 3. Non Hodgkin lymphoma CD 20 negative 4. Mantle Cell Lymphoma 5. Follicular Non Hodgkin Lymphoma grade I-II-IIIa 6. Primitive mediastinal diffuse large B cell lymphoma with only mediastinal involvement 7. International Prognostic Index at low risk (1) 8. Has known or suspected hypersensitivity or intolerance to rituximab 9. History of evolutive malignancy within the last 3 years other than squamous cell and basal cell carcinoma.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the feasibility and safety of a treatment regimen including Lenalidomide plus Rituximab-CHOP (LR-CHOP) through the definition of the DLT of lenalidomide when delivered in combination with R-CHOP To evaluate the response rate of LR-CHOP in elderly patients with DLBCL at diagnosis at the MTD of Lenalidomide. Overall response rate;Secondary Objective: To evaluate long term efficacy of LR-CHOP with lenalidomide delivered at the MTD in elderly patients with DLBCL at diagnosis.;Primary end point(s): Evaluation of feasibility and toxicity of the regimen according to the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Definition of Dose Limiting Toxicity (DLT) considered as the maximum dose inducing any Grade > 3 non-hematologic toxicity, or a delay > 15 days of planned cycle date. Complete response and overall response rate; | — |
Countries
Germany, Italy
Outcome results
None listed