previously untreated Binet stage A CLL patients at high risk of disease progression MedDRA version: 9.1 Level: LLT Classification code 10008943 Term: Chronic leukaemia
Conditions
Interventions
Trade Name: MABCAMPATH
Pharmaceutical Form: Solution for injection
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 30-
Sponsors
G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Previously untreated male and female patients with Binet stage A CLL who do not necessitate therapy, according to NCI criteria and newly diagnosed not more than 12 months before registration . 7.1 Inclusion Criteria 1 Established diagnosis of B-CLL by NCI criteria, performed by local haematologist. Diagnosis will be confirmed by the biological review committee according to flow cytometry analysis CD5 /CD19 /CD23 . 2 Age 18 years and 70 years 3 Binet stage A Appendix B 4 Diagnosis performed within 12 months before inclusion in the study 5 All patients with Binet stage A disease who do not necessitate therapy by NCI criteria guidelines should be included 6 Patients at high risk of disease progression for the presence of 2 or more of the following risk factors a CD38 30 b Zap-70 strong at Western Blot analysis c IgVH status unmutated degree of homology 2 7 ECOG performance status 0 2 Appendix C 8 ................... 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: 1 Patients with CLL whose diagnosis exceed 12 months before inclusion in the study 2 Age 70 and 18 years 3 ECOG performance status 2 4 Patients with leukemic phase of lymphoproliferative disorders of B-cell origin CD5- and/or CD23- according to flow cytometry analysis 5 Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease 6 Medical condition requiring the prolonged estimated to be more than one month use of oral corticosteroids 7 History of anaphylactic reaction following exposure to humanized monoclonal antibodies 8 Patients with active bacterial, viral or fungal infection 9 HIV positivity, HBV and HBC positivity assessed by DNA copies 10 CMV status as evaluated by pathological values detected by CMV specific quantitative 11 ............
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: A comparison of the effect of immediate treatment with CAM versus deferred treatment in clinical Binet stage A patients at high risk for disease progression, in terms of Progression Free Survival PFS .;Secondary Objective: For all patients 1. Quality of Life QoL 2. Event Free Survival EFS /Time to Treatment Failure TTF 3. Time to next treatment 4. Time to second treatment 5. Overall survival OS For patients included in the early treatment arm 1.Complete Response CR , Partial Response PR and Overall Response Rate ORR . 2. Safety profile of early treatment with CAM For patient in the early treatment arm achieving CR 1. Minimal Residual Disease MDR detected by flow-cytometry 2. Disease free survival DFS , calculated from the date of the response achievement to the date of relapse;Primary end point(s): - Progression Free survival PFS | — |
Countries
Italy
Outcome results
None listed