Phase 3
Completed N=234
A Study of MabThera (Rituximab) in Elderly Patients With Untreated Follicular Non-Hodgkin's Lymphoma (NHL)
Source: ClinicalTrials.gov NCT01144364 ↗Enrolled (actual)
234
Serious AEs
12.6%
Results posted
Dec 2014
Primary outcomePrimary: Percentage of Participants With Disease Progression or Death — 29.7; 34.7 percentage of participants — p=0.254
Summary
This study will evaluate the efficacy and safety of brief induction therapy with a chemotherapeutic regimen containing MabThera, followed by either maintenance therapy with MabThera or no further therapy. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Disease Progression or Death |
29.7; 34.7 | 0.254 |
| PRIMARY PFS Randomization- Percentage of Participants Estimated to be Free of Progression at 12, 24, and 34 Months |
92.0; 82.5; 81.0; 68.9; 70.4; 62.3 | 0.079 |
| SECONDARY Percentage of Participants Estimated to be Free of Progression at 12, 24, and 36 Months |
90.1; 77.8; 65.7 | — |
| SECONDARY Disease-Free Survival (DFS) From Randomization - Percentage of Participants Disease Free at 12, 24, and 36 Months |
93.0; 82.5; 82.7; 68.9; 69.2; 62.3 | 0.105 |
| SECONDARY Overall Survival (OS) From Randomization - Percentage of Participants Estimated to be Alive at 12, 24, and 34 Months |
97.0; 100; 96.0; 96.9; 96.0; 95.8 | 0.751 |
| SECONDARY Overall Survival (OS) From Randomization - Percentage of Participants With Death |
5.0; 4.0 | 0.751 |
| SECONDARY OS From Enrollment - Percentage of Participants Estimated to be Alive at 12, 24, and 36 Months |
94.9; 92.7; 89.5 | — |
| SECONDARY Percentage of Participants With a Response During the Induction Phase |
79.2; 79.2; 19.8; 19.8; 1.0; 0.0 | — |
| SECONDARY Percentage of Participants With a Molecular Response in the Induction Phase |
36.4; 58.5 | — |
| SECONDARY Duration of Response Using a Traditional Approach - Percentage of Participants Estimated to Have a Sustained Response at 12, 24, and 34 Months |
93.9; 82.3; 83.6; 68.6; 69.9; 61.9 | 0.103 |
| SECONDARY Duration of Response Using the Competing Risk Approach - Cumulative Percentage of Participants With Progression, Relapse or Death as a Result of FL at 12, 24, and 34 Months |
6.1; 17.7; 16.2; 31.4; 29.5; 38.0 | 0.084 |
Eligibility Criteria
Inclusion Criteria
- adult patients 60-75 years of age;
- B-cell follicular NHL;
- no previous treatment;
- active disease, with rapid progression.
Exclusion Criteria
- other cancer within 3 years of study, except carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer, or ductal carcinoma in situ of the breast treated with lumpectomy;
- long-term use (>1 month) of systemic corticosteroids;
- central nervous system involvement;
- history of significant cardiovascular disease;
- positive test result for HIV, or hepatitis B or C.
Data sourced from ClinicalTrials.gov (NCT01144364). 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.