Phase 2
Completed N=38
A Study of MabThera/Rituxan (Rituximab) in Patients With Relapsed Centroblastic Centrocytic Non-Hodgkin's Lymphoma
Source: ClinicalTrials.gov NCT01998893 ↗Enrolled (actual)
38
Serious AEs
26.3%
Results posted
Nov 2014
Primary outcomePrimary: Percentage of Participants With a Complete Remission (CR) or Partial Remission (PR) — 39.5 percentage of participants
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.
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 | — |
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.
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. Informational only — not medical advice.