CHRONIC LYMPHATIC LEUKEMIA, LYMPHOCYTIC LYMPHOMA MedDRA version: 9.1 Level: LLT Classification code 10052178
Conditions
Interventions
Trade Name: MABTHERA*EV 1FL 50ML 500MG
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Rituximab
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentrat
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of efficacy (in terms of achievement of CR, CR with MRD negative, PR, SD) and tolerability (toxicity profile) of the therapy R-2CdA and Rituximab maintenance (compared with historical data);Primary end point(s): • Duration of response (also maintenance of molecular response) and TTP: compared with TTP between the two groups (R-2CdA – historical data vs R-2cda+R) to demonstrate efficacy of maintenance in extending the duration of response;Secondary Objective: • Evaluation of clinical-biological variables, including ZAP-70 and cytogenentics in FISH, that can influence response • Pharmacogenomic study in correlation with response to induction R-2CdA treatment • Evaluation of immunological structure by means of CD4 and CD8 counts during and at the end of therapy with R-2CdA and R maintenance | — |
Countries
Italy
Outcome results
None listed