An Open-label, Multicentre,Dose-escalating Phase I/II Study, With a Randomised Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Lymphoma
Both
Lymphoma
Trial Information
An Open-label, Multicentre,Dose-escalating Phase I/II Study, With a Randomised Phase II Part, to Investigate the Safety and Tolerability of RO5072759 Given as Monotherapy in Patients With CD20+ Malignant Disease
Inclusion Criteria:
- adult patients, >=18 years of age;
- part 1 only: CD20+ malignant disease (lymphoma or CLL);
- part 2 only: relapsed or refractory DLBCL, follicular NHL, CLL or MCL.
Exclusion Criteria:
- prior use of any investigational antibody therapy or other agent within 6 months of
study start;
- prior use of any anti-cancer vaccine;
- prior use of MabThera within 8 weeks of study entry;
- CNS lymphoma.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Phase 1: Incidence of dose-limiting toxicity.
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
France: AFSSAPS
Study ID:
BO20999
NCT ID:
NCT00517530
Start Date:
September 2007
Completion Date:
January 2014
Related Keywords:
- Lymphoma
- Lymphoma
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