Rituximab-2cda + Rituximab maintenance in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma - ND

• Conditions: CHRONIC LYMPHATIC LEUKEMIA, LYMPHOCYTIC LYMPHOMA; MedDRA version: 9.1Level: LLTClassification code 10052178

• Registration Number: EUCTR2010-018519-14-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

•Aged = 18 years
•Patients affected by CLL / SLL
•Presence of active disease defined as the presence of one of the following:
?Disease related symptoms (weight loss >10% in the last 6 months, fever >38? C for 2 weeks without evidence of infection, or marked asthenia, or profuse sweating without evidence of infection)
?Massive nodes (at least 10 cm in longest diameter) or progressive or symptomatic lymphadenopathy
?Massive (at least 6 cm below left costal margin) or progressive or symptomatic splenomegaly
?Progressive lymphocytosis (increased >50% in 2 months) or lymphocyte doubling time < 6 months
?Evidence of progressive bone marrow insufficiency seen as evidence of or worsening of anemia and or thrombocytopenia
?Autoimmune anemia and or thrombocytopenia that is poorly responsive to corticosteroids or other standard therapy
•ECOG = 2
•Written informed consent
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

•Patients with cardiac, pulmonary, neurological, psychiatric or serious metabolic conditions not related to CLL / SLL
•Altered hepatic function not attributable to CLL / SLL
•Altered renal function
•Patients with positive sierolgy for HBSAG or HBCAB without evaluation by a hepatologist
•Patients with positive serology for HIV or with other serious immunosupressive conditions

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified