Chronic Lymphocytic leukemia MedDRA version: 9.1 Level: LLT Classification code 10008956 Term: Chronic lymphatic leukaemia
Conditions
Interventions
Product Name: FOSTAMATINIB DISODIUM R788
Pharmaceutical Form: Tablet
CAS Number: 914295-16-2
Current Sponsor code: R788
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration numb
Sponsors
POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: B-CLL (NCI Working group criteria) and:  Disease response to previous induction chemo-immunotherapy (PR or CR with MRD) after almost 2 months from the end of induction therapy;  Age≥50 years;  Written informed consensus Approved by Ethical committee, dated and signed;  Performance status, (World Health Organization criteria) ≤ to2;  Life expectance >6 months 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
Exclusion criteria:  Stable or progressive disease after chemo-immunotherapy;  Complete Remission with absence of MRD;  Delivery or breast feeding;  Age ≤ 50 years;  Active secondary malignancies  Active infection disease  Patients unwilling or unable to comply with the protocol for medical, familiar, geographic, psycho-social problem.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: tolerability;Secondary Objective: - Progression free survival - Effect of treatment on expression of major apoptosis-regulatory proteins (Mcl-1, Bcl-2, Bax, Bim);Primary end point(s): nd | — |
Countries
Italy
Outcome results
None listed