First line treatment with rituximab plus fludarabine, cyclophosphamide, mitoxantrone (R-FCM) and maintenance therapy with rituximab in patients diagnosed with chronic lymphocytic leukemia. Tratamiento de primera línea con rituximab combinado con fluradabina, ciclofosfamida y Mitoxantrone (R-FCM) y mantenimiento con rituximab de pacientes con leucemia linfática crónica (LLC) - R-FCM in C
- Conditions
- Patients diagnosed with chronic lymphocytic leukemia (CLL) according to the WHO guidelines, within 18 and 71 years and not previously treated
- Registration Number
- EUCTR2005-001569-33-ES
- Lead Sponsor
- Dept. Hematology, Hospital Clinic
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 60
1. Age > 17 and < 71 years
2. ECOG = 3
3. Patients diagnosed with CLL according to the standard criteria
4. Active disease defined with the presence of one of the following:
- weight loss > 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
- Age < 18 and > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>2. Relationship between biological markers and response<br>3. Response duration and progression free survival<br>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. <br>2. Response rate of the R-FCM<br>3. Relationship between biological markers and response<br>4. Response duration and progression free survival<br>5. Pharmacokynetic parameters
- Secondary Outcome Measures
Name Time Method