Trial information
A Study of MabThera (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
Status: No longer recruiting
Protocol number: ML16865
Sponsor: F Hoffman-La Roche Ltd
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of MabThera alone and in combination with Roferon-A on time to treatment failure in patients with follicular or other low-grade lymphoma
Brief summary: This study will compare the efficacy and safety of MabThera alone, and in combination with interferon-alfa 2a (Roferon-A) in patients with follicular or other CD20+ low-grade lymphoma. . Patients who have a response will receive an additional cycle of treatment. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
Target sample size is
313.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Lymphomas
Intervention type: Drug
Intervention name: rituximab[MabThera/Rituxan]
Primary outcome: 1. Efficacy: Time to treatment failure
Key secondary outcomes: 1. Efficacy: Clinical objective response rate, response duration, time to progression, overall survival, molecular response
Safety: Adverse events, laboratory parameters
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).
Exclusion criteria:
- prior treatment with rituximab or an interferon;
- B-CLL, mantle cell lymphoma, lymphoplasmacytic lymphoma (Waldenstroem's disease), or central nervous system lymphoma;
- prior malignancies, except non-melanoma skin tumors, in situ cervical cancer, or curative surgery >5 years ago;
- positive test result for human immunodeficiency virus;
- uncontrolled asthma or allergy requiring corticosteroids.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: October, 2002
Trial registration date: 09/26/2005
Date last updated: 12/2/2008
Link to trial result
This trial was conducted at the following locations:
Denmark
Norway
- Bergen
- Oslo
- Stavanger
- Tromsø
- Trondheim
Sweden
- Eskilstuna
- Falun
- Halmstad
- Huddinge
- Jonkoping
- Karlstad
- Linkoeping
- Lulea
- Lund
- Malmoe
- Oerebro
- Stockholm
- Sundsvall
- Umea
- Uppsala
- Västerås
- Vaxjo
- Visby
