Phase 2 N=38 Treatment

A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma

Non-Hodgkin's Lymphoma

Bottom Line

View on ClinicalTrials.gov: NCT01998893 ↗

Enrolled (actual)

Serious AEs

26.3%

Results posted

Nov 2014

Primary outcome: Primary: Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) — 39.5 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: rituximab [MabThera/Rituxan] (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hoffmann-La Roche
Primary completion: Feb 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR)	39.5	—
SECONDARY Number of Participants With a Clinical Response	9; 6; 3; 16; 2; 2	—
SECONDARY Time to Best Response	1.9	—
SECONDARY Duration of Remission	12.7	—
SECONDARY Time to Progression	6.6	—
SECONDARY Overall Survival (OS)	49.6	—
SECONDARY Number of Participants With a Clinical Response to Re-Treatment	1; 0; 0; 3; 0; 1	—

Summary

This study will evaluate the efficacy and safety of MabThera/Rituxan in patients with relapsed low-grade centroblastic centrocytic non-Hodgkin's lymphoma. Patients will receive once-weekly intravenous MabThera/Rituxan for 4 weeks; responding patients will be treated a second time in case of relapse (defined as progression after complete or partial response). The anticipated time on study treatment is <3 months.

Eligibility Criteria

Inclusion Criteria

adult patients >= 18 years of age;
centrocytic centroblastic non-Hodgkin's lymphoma stage III-IV;
relapse after chemotherapy (with or without interferon maintenance therapy).

Exclusion Criteria

primary refractory lymphomas;
more than 3 relapses of centroblastic centrocytic non-Hodgkin's lymphoma;
clinically significant cardiac disease.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01998893). 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.