Phase 4
N=545
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
Non-Hodgkin's Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00430352 ↗Enrolled (actual)
545
Serious AEs
20.4%
Results posted
Jun 2015
Primary outcome: Primary: Percentage of Participants With an Adverse Event (AE) - Overall Summary — 67.4; 5.8; 20.2; 0.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- rituximab [MabThera/Rituxan] (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hoffmann-La Roche
- Primary completion
- May 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With an Adverse Event (AE) - Overall Summary |
67.4; 5.8; 20.2; 0.2; 7.5; 3.0 | — |
| SECONDARY Progression-Free Survival - Percentage of Participants With an Event |
24.0 | — |
| SECONDARY Progression-Free Survival - Time to Event |
NA | — |
| SECONDARY Event-Free Survival (EFS) - Percentage of Participants With an Event |
24.4 | — |
| SECONDARY Event-Free Survival (EFS) - Time to Event |
NA | — |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
7.3 | — |
| SECONDARY Overall Survival (OS) - Time to Event |
NA | — |
| SECONDARY Time to Next Lymphoma Treatment (NLT) - Percentage of Participants With an Event |
17.4 | — |
| SECONDARY Time to NLT - Time to Event |
NA | — |
| SECONDARY Percentage of Participants With Response by Best Response to Study Treatment |
2.1; 87.5; 10.5 | — |
| SECONDARY Percentage of Participants With PR Who Converted to CRu |
6.2 | — |
Summary
This single arm study will evaluate the safety and efficacy of MabThera maintenance therapy following a MabThera-containing induction regimen in first line or relapsed patients with follicular non-Hodgkin's lymphoma. All patients will receive MabThera 375mg/m2 body surface area, as an intravenous infusion, every 8 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 500+ individuals.
Eligibility Criteria
Inclusion Criteria
- adult patients, >=18 years of age;
- histologically confirmed grade 1, 2 or 3a follicular non-Hodgkin's lymphoma;
- patients who have received adequate (>=8 cycles) induction therapy with MabThera as first line treatment, or treatment for relapsed disease;
- demonstrated partial or complete response to induction therapy.
Exclusion Criteria
- stable or progressive disease after most recent induction therapy;
- transformation to high grade lymphoma;
- patients with prior or concomitant malignancies, except non-melanoma skin cancer or adequately treated in situ cancer of the cervix.
Data sourced from ClinicalTrials.gov (NCT00430352). 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.