Clinical trial NCT01609010: A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
Official title: Rituximab (Mabthera®) as Single Agent and in Combination With Interferon Alfa-2a (Roferon-A®), a Phase-III Randomized Trial in Patients With Follicular or Other CD20+ Low-grade (Indolent) Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
Collaborators: name: Nordic Lymphoma Group
First posted: 2012-05-31
Enrollment: 313
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: Treatment Failure - Percentage of Participants With an Event
timeFrame: Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Treatment Failure - Time to Event
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Secondary outcomes:
measure: Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)
timeFrame: Weeks 10 and 16
measure: Percentage of Participants Achieving CR or CRu
timeFrame: Weeks 10 and 16
measure: Duration of Response - Percentage of Participants With an Event
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Duration of Response
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Disease Progression - Percentage of Participants With an Event
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Time to Disease Progression
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Overall Survival (OS) - Percentage of Participants With an Event
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
measure: Overall Survival
timeFrame: BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Other outcomes:
Locations:
city: Hillerod
country: Denmark
city: København
country: Denmark
city: Roskilde
country: Denmark
city: Bergen
country: Norway
city: Oslo
country: Norway
city: Oslo
country: Norway
city: Stavanger
country: Norway
city: Tromsø
country: Norway
city: Trondheim
country: Norway
city: Eskilstuna
country: Sweden
city: Falun
country: Sweden
city: Goeteborg
country: Sweden
city: Halmstad
country: Sweden
city: Huddinge
country: Sweden
city: Jonkoping
country: Sweden
city: Karlstad
country: Sweden
city: Kristianstad
country: Sweden
city: Linkoeping
country: Sweden
city: Luleå
country: Sweden
city: Lund
country: Sweden
city: Malmoe
country: Sweden
city: Stockholm
country: Sweden
city: Stockholm
country: Sweden
city: Sundsvall
country: Sweden
city: Uddevalla
country: Sweden
city: Umea
country: Sweden
city: Uppsala
country: Sweden
city: Vaxjo
country: Sweden
city: Visby
country: Sweden
city: Västerås
country: Sweden
city: Örebro
country: Sweden
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
citation: Kimby E, Ostenstad B, Brown P, Hagberg H, Erlanson M, Holte H, Linden O, Johansson AS, Ahlgren T, Wader K, Wahlin BE, Delabie J, Sundstrom C; Nordic Lymphoma Group (NLG). Two courses of four weekly infusions of rituximab with or without interferon-alpha2a: final results from a randomized phase III study in symptomatic indolent B-cell lymphomas. Leuk Lymphoma. 2015;56(9):2598-607. doi: 10.3109/10428194.2015.1014363. Epub 2015 Mar 11.