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-FR
- 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
- Secondary Outcome Measures
Name Time Method