Prospective Randomized Trial of Immediate Treatment with Campath versus Deferred Therapy in Patients with Previously Untreated Binet Stage A B-Cell Chronic Lymphocytic Leukemia at High Risk for Disease Progression - ND

• Conditions: previously untreated Binet stage A CLL patients at high risk of disease progression; MedDRA version: 9.1Level: LLTClassification code 10008943Term: Chronic leukaemia

• Registration Number: EUCTR2006-006915-61-IT
• Lead Sponsor: G.I.S.L. - GRUPPO ITALIANO STUDIO LINFOMI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03-09
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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 ............

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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