R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma

• Status: Terminated
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to confirm the efficacy of the association of R-2cda in patients affected by Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma and of evaluating the efficacy of prolongation of therapy with additional infusions of Rituximab alone in increasing and prolonging the duration of the response.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Institute of Oncology
• Treatments: Cladribine; Rituximab

Criteria

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

Exclusion Criteria:

• Age < 18 years

• Patients with cardiac, pulmonary, neurological, psychiatric or serious metabolic conditions not related to CLL / SLL

• Altered hepatic function (bilirubin, GOT, GPT, or gammaGT > 2 times upper limit of normal) not attributable to CLL / SLL

• Altered renal function (creatinine > 1,5 times upper limit of normal)

• Patients with serious active infections

• Pregnancy and/ or breastfeeding

• Patients with positive serology for HBSAG or HBCAB without evaluation by a hepatologist

• Patients with positive serology for HIV

• Life expectancy of less than 12 months

• Not taking any other experimental drugs

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to Cladribine (2CdA).