Patients diagnosed with chronic lymphocytic leukemia (CLL) according to the WHO guidelines, within 18 and 71 years and not previously treated
Conditions
Interventions
Trade Name: MabThera®
Product Name: MabTheta
Product Code: Ro 45-2294
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Rituximab
CAS Number: 174722-31
Concentration uni
Sponsors
Dept. Hematology, Hospital Clinic
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age > 17 and 10% within the previous 6 months - Extreme fatigue - Fever > 38oC for > 2 weeks without evidence of infection - Night sweets without evidence of infection - Progressive bone marrow failure as manifested by the development of anemia and/or thrombocytopenia - massive or progressive splenomegaly - massive or progressive lymphadenopathy - progressive lymphocytosis with an increase of > 50% over a 2-month period, or anticipated doubling time of less than 6 months - Patients not previously treated - Informed consent signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: - Age 70 years - previously treated patients - Transformed CLL to a more hystological agressive forms - patients with severe cardiac, pulmonar, neurological, psychiatric or metabolical conditions. - patients receiving high dose of corticosteroid therapies - abnormal hepatic (bilirrubin, ASAT, ALAT, GGT > 2 times the normal values) not related to the CLL - abnormal renal function (creatinin > 1.5 times the normal value or clearance of creatinine < 50 mL/min - Patients diagnosed with other neoplastic conditions (except for localized cutaneous carcinoma) - autoimmune anemia or thrombocytopenia or positive Coombs's test - severe and active infection - pregnancy or breast feeding period - HIV positivity or other sever immunosupressive diseases - Positive HBsAg, HBcAb, or CHV - Participation in another clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus maintenance treatment with rituximab. ;Secondary Objective: 1. Response rate of the R-FCM 2. Relationship between biological markers and response 3. Response duration and progression free survival 4. Pharmacokynetic parameters;Primary end point(s): 1. To asess feasibility and toxicity of the quemotherapeutic regimen rituximab, fludarabine, cyclophosphamide, and mitoxantrone (R-FCM) plus treatment maintenance with rituximab. 2. Response rate of the R-FCM 3. Relationship between biological markers and response 4. Response duration and progression free survival 5. Pharmacokynetic parameters | — |
Countries
Spain
Outcome results
None listed