Trials / Completed
CompletedNCT00738374
A Study of MabThera (Rituximab) Plus Chlorambucil in Patients With Previously Untreated Chronic Lymphocytic Leukemia.
A Study of Chlorambucil Plus MabThera as Induction Therapy Followed in Responders by Maintenance Therapy Versus Observation on Response Rate in Patients >=60 Years With Previously Untreated Chronic Lymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 97 (actual)
- Sponsor
- Hoffmann-La Roche · Industry
- Sex
- All
- Age
- 60 Years
- Healthy volunteers
- Not accepted
Summary
This single arm study will assess the efficacy and safety of MabThera + chlorambucil as induction therapy, followed in responders by maintenance therapy or observation in elderly patients with previously untreated chronic lymphocytic leukemia. During the induction phase patients will receive 2 x 4 weekly courses of chlorambucil followed by 8 x 4 weekly courses of chlorambucil + MabThera. Subsequently, responders will be randomized to receive 12 doses of MabThera given every 8 weeks, or no further treatment. The anticipated time on study treatment is 2+ years, and the target sample size is \<100 individuals.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rituximab [MabThera/Rituxan] | 375mg/m2 iv on day 1 of course 3; 500mg/m2 iv on day 1 of courses 4-8 (induction phase); 375mg/m2 iv every 8 weeks (maintenance phase). |
| DRUG | chlorambucil | 8mg/m2 po on days 1-7 of courses 1-8 |
Timeline
- Start date
- 2008-11-03
- Primary completion
- 2013-01-14
- Completion
- 2013-01-14
- First posted
- 2008-08-20
- Last updated
- 2017-08-15
- Results posted
- 2015-02-16
Locations
20 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT00738374. Inclusion in this directory is not an endorsement.