A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma
This study has been completed.
Sponsor:
Hoffmann-La Roche
Collaborator:
Nordic Lymphoma Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609010
First received: May 29, 2012
Last updated: January 14, 2013
Last verified: January 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lymphoma |
Drug: rituximab [MabThera/Rituxan] Drug: interferon alfa-2a [Roferon-A] |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Time to treatment failure [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical objective response rate (complete and partial response) [ Time Frame: approximately 3 years ] [ Designated as safety issue: No ]
- Molecular response rate (blood/bone marrow) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Time to progression [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
- Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 302 |
| Study Start Date: | October 2002 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: A: MabThera |
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv weekly, 4-week cycles
Other Name: MabThera/Rituxan
|
| Experimental: B: MabThera + Roferon |
Drug: rituximab [MabThera/Rituxan]
375 mg/m2 iv weekly, weeks 3-6 of a 6-week cycle
Drug: interferon alfa-2a [Roferon-A]
3 MIU/day sc in Week 1 followed by 4.5 MIU/day sc in Weeks 2-5 of a 6-week cycle
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01609010
Locations
| Denmark | |
| Hillerød, Denmark, 3400 | |
| København, Denmark, 2100 | |
| Roskilde, Denmark, 4000 | |
| Norway | |
| Bergen, Norway, 5021 | |
| Oslo, Norway, 0310 | |
| Oslo, Norway, 0407 | |
| Stavanger, Norway, 4068 | |
| Tromsø, Norway, 9038 | |
| Trondheim, Norway, 7000 | |
| Sweden | |
| Eskilstuna, Sweden, 63188 | |
| Falun, Sweden, 79182 | |
| Goeteborg, Sweden, 41685 | |
| Halmstad, Sweden, 30185 | |
| Huddinge, Sweden, 14186 | |
| Jonkoping, Sweden, 55185 | |
| Karlstad, Sweden, 65185 | |
| Kristianstad, Sweden, 29185 | |
| Linkoeping, Sweden, 58185 | |
| Luleå, Sweden, S-971 80 | |
| Lund, Sweden, 22185 | |
| Malmoe, Sweden, 21401 | |
| Stockholm, Sweden, 17176 | |
| Stockholm, Sweden, 11883 | |
| Sundsvall, Sweden, 85186 | |
| Uddevalla, Sweden, 45180 | |
| Umea, Sweden, 90185 | |
| Uppsala, Sweden, 751 85 | |
| Vaxjo, Sweden, 35185 | |
| Visby, Sweden, 62184 | |
| Västerås, Sweden, 72335 | |
| Örebro, Sweden, 701 85 | |
Sponsors and Collaborators
Hoffmann-La Roche
Nordic Lymphoma Group
Investigators
| Study Chair: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01609010 History of Changes |
| Other Study ID Numbers: | ML16865 |
| Study First Received: | May 29, 2012 |
| Last Updated: | January 14, 2013 |
| Health Authority: | Sweden: Medical Products Agency |
Additional relevant MeSH terms:
|
Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Interferon-alpha Interferon Alfa-2a Interferons Rituximab Antiviral Agents |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Immunologic Factors Physiological Effects of Drugs Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 19, 2013