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

Dept. Hematology, Hospital Clinic0 个研究点目标入组 60 人开始时间: 2005年9月5日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•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

发起方

Dept. Hematology, Hospital Clinic