EUCTR2009-012476-28-DEActive, not recruitingPhase 1
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.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- F.Hoffmann-La Roche Ltd
- Enrollment
- 786
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 262
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 524
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.
Investigators
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