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:
Collaborator:
Nordic Lymphoma Group
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609010
First received: May 29, 2012
Last updated: July 1, 2013
Last verified: July 2013
  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: July 2011
Primary Completion Date: July 2011 (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
Hillerod, Denmark, 3400
København, Denmark, 2100
Roskilde, Denmark, 4000
Norway
Bergen, Norway, 5021
Oslo, Norway, 0407
Oslo, Norway, 0379
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, 118 83
Sundsvall, Sweden, 85186
Uddevalla, Sweden, 45180
Umea, Sweden, 90185
Uppsala, Sweden, 751 85
Vaxjo, Sweden, 35185
Visby, Sweden, 62184
Västerås, Sweden, 72189
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: July 1, 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 April 17, 2014