Phase 2 N=48 Treatment

A Study of MabThera (Rituximab) Plus Standard Chemotherapy in Patients With Previously Untreated Mantle Cell Lymphoma.

Mantle Cell Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT00472420 ↗

Enrolled (actual)

Serious AEs

52.1%

Results posted

Nov 2014

Primary outcome: Primary: Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR) — 19; 8 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab [MabThera/Rituxan] (Drug); First line chemotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants Achieving Complete Remission (CR) (Including Unconfirmed CR [CR(u)]) or Partial Remission (PR)	19; 8	—
SECONDARY Progression Free Survival (PFS)	30.456	—
SECONDARY Event Free Survival (EFS)	40.049	—

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.

Eligibility Criteria

Inclusion Criteria

histologically-proven mantle cell lymphoma;
previously untreated disease at stage II, III and IV, requiring therapy.

Exclusion Criteria

known hypersensitivity reaction to rituximab, or known anti-murine antibody reactivity or known hypersensitivity to murine antibodies;
active malignancy other than mantle cell lymphoma within 5 years of start of study, with the exception of resected basal cell cancer, squamous cell cancer of the skin, or in situ cancer of the cervix;
serious disorders interfering with full standard dosing chemotherapy;
stage I disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00472420). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.