Status:
TERMINATED
R-2cda and Prolongation of Therapy With Rituximab Alone in Chronic Lymphocytic Leukaemia and Small Lymphocytic Lymphoma
Lead Sponsor:
European Institute of Oncology
Conditions:
Chronic Lymphocytic Leukaemia
Small Lymphocytic Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Chronic Lymphocytic Leukaemia (CLL) is a lymphoproliferative disorder characterized by the progressive accumulation of monoclonal peripheral B cells in bone marrow, peripheral blood and lymphoid tissu...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01446900
Start Date
January 1 2011
End Date
December 1 2017
Last Update
January 31 2018
Active Locations (1)
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1
European Institute of Oncology
Milan, Italy