Phase 3
Completed N=313
A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
Source: ClinicalTrials.gov NCT01609010 ↗Enrolled (actual)
313
Serious AEs
15.0%
Results posted
Jun 2014
Primary outcomePrimary: Treatment Failure - Percentage of Participants With an Event — 68; 67 percentage of participants
Summary
This randomized, open-label study will compare the efficacy and safety of MabThera/Rituxan (rituximab) alone, and in combination with Roferon-A (interferon alfa-2a) in patients with follicular or other CD20+ low-grade lymphoma. Patients will be randomized to receive either MabThera/Rituxan 375 mg/m2 intravenously weekly for 4 weeks or Roferon-A 3 MIU/day subcutaneously in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 plus MabThera/Rituxan 375 mg/m2 weekly iv in Weeks 3-6. Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is up to 6 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure - Percentage of Participants With an Event |
68; 67 | — |
| PRIMARY Treatment Failure - Time to Event |
21.5; 28.0 | 0.3023 |
| SECONDARY Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR) |
54; 59; 74; 82 | 0.3362 |
| SECONDARY Percentage of Participants Achieving CR or CRu |
8; 9; 24; 41 | 0.8540 |
| SECONDARY Duration of Response - Percentage of Participants With an Event |
63; 65; 44; 53; 38; 48 | — |
| SECONDARY Duration of Response |
22.0; 30.0; NA; 44.4; 59.5; 50.7 | 0.7840 |
| SECONDARY Disease Progression - Percentage of Participants With an Event |
60; 62 | — |
| SECONDARY Time to Disease Progression |
25.0; 32.0 | 0.8946 |
| SECONDARY Overall Survival (OS) - Percentage of Participants With an Event |
13; 11 | — |
| SECONDARY Overall Survival |
NA; NA | 0.4963 |
Eligibility Criteria
Inclusion Criteria
- Adult patients >18 years of age
- CD20+ low-grade (indolent) lymphoma of follicular and marginal zone type, small lymphocytic lymphoma without a B-CLL phenotype, or indolent lymphoma not otherwise specified
- Stage II (with bulky disease), III, or IV lymphoma
- No previous chemotherapy or a maximum of 6 months chlorambucil or cyclophosphamide
- Indication for treatment: symptomatic enlarged lymph nodes, spleen or other lymphoma manifestations, progression >6 months of lymphadenopathy or splenomegaly, anemia or thrombocytopenia or decreased hemoglobin or platelets due to lymphoma, general symptoms (weight loss, night sweats or fever)
- WHO performance status 0-2
Exclusion Criteria
- Prior treatment with rituximab or an interferon
- B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or central nervous system lymphoma
- Indolent lymphoma transformed into aggressive lymphoma
- Indolent lymphoma with bulky tumor requiring urgent therapy
- Prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or curative surgery >5 years ago
- Positive for HIV infection
- Uncontrolled asthma or allergy requiring corticosteroids
Data sourced from ClinicalTrials.gov (NCT01609010). 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.