Phase 2
Completed N=47
A Study of Induction and Maintenance Treatment With MabThera (Rituximab) in Patients With Indolent B-Cell Nonfollicular Lymphomas
Source: ClinicalTrials.gov NCT01153971 ↗Enrolled (actual)
47
Serious AEs
34.0%
Results posted
Aug 2014
Primary outcomePrimary: Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date — 73.9 percentage of participants — p=<0.0001
Summary
This study will evaluate the efficacy and safety of MabThera in combination chemotherapy, followed by maintenance treatment with MabThera. The anticipated time on study treatment is 1-2 years, and the target sample size is <100 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Remaining Failure-Free After 2 Years From Treatment Start Date |
73.9 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving a Best Overall Response of CR, CRu, or PR by Study Phase |
95.7; 80.4 | — |
| SECONDARY Percentage of Participants Achieving a Response by Response Type and Study Phase |
41.3; 45.7; 45.7; 21.7; 15.2; 19.6 | — |
| SECONDARY Failure-Free Survival (FFS), Percentage of Participants Estimated to be Free of Documented Disease Progression, Relapse, or Death |
90.12 | — |
| SECONDARY FFS - Percentage of Participants With an Event |
8.7 | — |
| SECONDARY FFS - Time to Event |
39.14 | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants Estimated to be Alive |
97.44 | — |
| SECONDARY OS - Percentage of Participants With an Event |
2.17 | — |
| SECONDARY OS - Time to Event |
38.6 | — |
| SECONDARY Disease-Free Survival (DFS) - Percentage of Participants Estimated to be Disease-Free |
87.70 | — |
| SECONDARY DFS - Percentage of Participants With an Event |
10.34 | — |
| SECONDARY DFS - Time to Event |
32.51 | — |
| SECONDARY Progression-free Survival (PFS) - Percentage of Participants Estimated to Be Progress Free |
90.12 | — |
| SECONDARY PFS - Percentage of Participants With an Event |
8.70 | — |
| SECONDARY PFS - Time to Event |
39.14 | — |
| SECONDARY Duration of Response (DR) - Percentage of Participants Expected to Maintain a Response |
90.07 | — |
| SECONDARY DR - Percentage of Participants With an Event |
9.09 | — |
| SECONDARY DR - Time to Event |
32.19 | — |
Eligibility Criteria
Inclusion Criteria
- adult patients 18-65 years of age;
- previously untreated indolent nonfollicular non-Hodgkin's lymphoma;
- active disease;
- >=3 involved sites.
Exclusion Criteria
- typical chronic lymphocytic leukemia;
- other malignancies within 3 years before study, except basal or squamous cell skin cancer or cancer in situ of the cervix;
- systemic corticosteroid use for >1 month;
- significant cardiovascular disease;
- central nervous system involvement;
- hepatitis B or C virus infection, or HIV infection.
Data sourced from ClinicalTrials.gov (NCT01153971). 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.