At a glance
ClinicalIndex Comparison Record- ✓Histologically-proven mantle cell lymphoma
- ✓Previously untreated disease
- ✓Stage II, III, or IV disease requiring therapy
- ✕Known hypersensitivity to rituximab or murine antibodies
- ✕Active malignancy other than MCL within 5 years (except resected skin cancers or cervical CIS)
- ✕Serious disorders interfering with full standard dosing chemotherapy
- ✕Stage I disease
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Study of the Effect of the Addition of MabThera to Standard Chemotherapy on Clinical Response in Patients With Previously Untreated Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating rituximab [MabThera/Rituxan] and First line chemotherapy for Mantle Cell Lymphoma. Completed, enrolled 48 participants across 7 sites.
Detailed Summary
This single arm study will evaluate the benefit of adding MabThera to standard induction chemotherapy in patients with newly diagnosed mantle cell lymphoma. The safety and tolerability of a MabThera-containing first line regimen will also be assessed. All patients will receive MabThera (375mg/m2 iv) every 3 weeks for 8 cycles, in combination with standard chemotherapy. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.
Study Details
Timeline
Interventions
375mg/m2 iv every 3 weeks
As prescribed