A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
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
1 other identifier
interventional
313
3 countries
31
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 lymphoma
Started Oct 2002
Typical duration for phase_3 lymphoma
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 29, 2012
CompletedFirst Posted
Study publicly available on registry
May 31, 2012
CompletedResults Posted
Study results publicly available
June 25, 2014
CompletedSeptember 8, 2014
August 1, 2014
8.8 years
May 29, 2012
May 23, 2014
August 29, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Treatment Failure - Percentage of Participants With an Event
Treatment failure was defined as an event of any of the following: progressive disease while receiving study treatment, death due to any cause, or the initiation of another type of treatment due to stable disease, progressive disease or relapse, or intolerance to study treatment.
Baseline (BL), Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Treatment Failure - Time to Event
The median time, in months, between randomization and treatment failure event determined using Kaplan-Meier estimates.
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Secondary Outcomes (8)
Percentage of Participants Achieving Complete Response (CR), Unconfirmed CR (CRu), or Partial Response (PR)
Weeks 10 and 16
Percentage of Participants Achieving CR or CRu
Weeks 10 and 16
Duration of Response - Percentage of Participants With an Event
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Duration of Response
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
Disease Progression - Percentage of Participants With an Event
BL, Week 10 and 16, and Months 6, 12, 18, 24, 30, and 42 of the follow-up period
- +3 more secondary outcomes
Study Arms (2)
Rituximab Monotherapy
ACTIVE COMPARATORParticipants received 375 milligrams per square meter (mg/m2) rituximab intravenously (i.v.) weekly for 4 weeks. Participants achieving minor response (MR), partial response (PR), or completer response (CR) received a second cycle of treatment.
Rituximab, Interferon
EXPERIMENTALParticipants received 375 mg/m2 rituximab i.v. weekly for 4 weeks; and 3 million international units per day (MIU/day) interferon-a2a subcutaneously (s.c.) during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5. Interferon-a2a was not administered on days of rituximab administration. Participants achieving MR, PR, or CR received a second cycle of treatment.
Interventions
375 mg/m2 rituximab i.v. weekly for 4 weeks
3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Nordic Lymphoma Groupcollaborator
Study Sites (31)
Unknown Facility
Copenhagen, 2100, Denmark
Unknown Facility
Hillerød, 3400, Denmark
Unknown Facility
Roskilde, 4000, Denmark
Unknown Facility
Bergen, 5021, Norway
Unknown Facility
Oslo, 0379, Norway
Unknown Facility
Oslo, 0407, Norway
Unknown Facility
Stavanger, 4068, Norway
Unknown Facility
Tromsø, 9038, Norway
Unknown Facility
Trondheim, 7000, Norway
Unknown Facility
Eskilstuna, 63188, Sweden
Unknown Facility
Falun, 79182, Sweden
Unknown Facility
Gothenburg, 41685, Sweden
Unknown Facility
Halmstad, 30185, Sweden
Unknown Facility
Huddinge, 14186, Sweden
Unknown Facility
Jönköping, 55185, Sweden
Unknown Facility
Karlstad, 65185, Sweden
Unknown Facility
Kristianstad, 29185, Sweden
Unknown Facility
Linköping, 58185, Sweden
Unknown Facility
Luleå, S-971 80, Sweden
Unknown Facility
Lund, 22185, Sweden
Unknown Facility
Malmo, 21401, Sweden
Unknown Facility
Örebro, 701 85, Sweden
Unknown Facility
Stockholm, 118 83, Sweden
Unknown Facility
Stockholm, 17176, Sweden
Unknown Facility
Sundsvall, 85186, Sweden
Unknown Facility
Uddevalla, 45180, Sweden
Unknown Facility
Umeå, 90185, Sweden
Unknown Facility
Uppsala, 75185, Sweden
Unknown Facility
Vaxjo, 35185, Sweden
Unknown Facility
Västerås, 72189, Sweden
Unknown Facility
Visby, 62184, Sweden
Related Publications (1)
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.
PMID: 25686644DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Nonserious AEs presented in this record include all AEs reported during the study, not just nonserious events, and information is presented by SOC as AE data by preferred term were not available within specified parameters (with 5% threshold).
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffman-LaRoche
Study Officials
- STUDY CHAIR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 29, 2012
First Posted
May 31, 2012
Study Start
October 1, 2002
Primary Completion
July 1, 2011
Study Completion
July 1, 2011
Last Updated
September 8, 2014
Results First Posted
June 25, 2014
Record last verified: 2014-08