An open-label, multi-center, three arm randomized, phase III study to compare the efficacy and safety of RO5072759 + chlorambucil (GClb), rituximab + chlorambucil (RClb)or chlorambucil (Clb) alone in previously untreated CLL patients with comorbidities.

Phase 1

Conditions: Patients with previously untreated B-CLL with comorbidities.
MedDRA version: 12.0Level: LLTClassification code 10003946Term: B-Lymphocytic, CLL (Kiel Classification)

Registration Number: EUCTR2009-012476-28-NL

Lead Sponsor: F.Hoffmann-La Roche

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 786

Inclusion Criteria

1. Adult patients, aged 18 years or older
2. Have documented CD20+ B-CLL
3. Previously untreated CLL requiring treatment according to the NCI criteria (Hallek,M; Blood 2008)

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. Prior CLL therapy
2. Transformation of CLL to aggressive NHL (Richter’s transformation)
3. History of other malignancy unless the malignancy has been in remission without treatment for = 2 years prior to enrolment.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To demonstrate clinically relevant statistical superiority in progression-free survival (PFS) with GClb compared to RClb and Clb alone and RClb compared to Clb [GClb vs Clb; GClb vs RClb; RClb vs Clb] in previously untreated CLL patients with comorbidities. ;Secondary Objective: • To evaluate PFS based on IRC<br>• To evaluate PFS censoring pts who started new anti-leukemic therapy before showing signs of disease progression<br>• To evaluate and compare in each arm: OR rate, CR and PR after the end of treatment, best OR rate achieved during treatment or within 6 m of end of treatment, event-free survival, disease-free survival in CR/CRi patients, and duration of response in CR/CRi and PR pts<br>(for more details please see the study protocol);Primary end point(s): Progression Free Survival

Secondary Outcome Measures