A Study of MabThera/Rituxan (Rituximab) Alone and in Combination With Roferon-A in Patients With Follicular or Other CD20+ Low-Grade (Indolent) Lymphoma

NCT ID: NCT01609010

Last Updated: 2014-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 313 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-10-31
• Study Completion Date: 2011-07-31

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.

Conditions

Lymphoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Rituximab Monotherapy

Participants 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.

Group Type: ACTIVE_COMPARATOR

rituximab

Intervention Type: DRUG

375 mg/m2 rituximab i.v. weekly for 4 weeks

Rituximab, Interferon

Participants 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.

Group Type: EXPERIMENTAL

rituximab

Intervention Type: DRUG

375 mg/m2 rituximab i.v. weekly for 4 weeks

interferon-a-2a

Intervention Type: DRUG

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

Interventions

rituximab

375 mg/m2 rituximab i.v. weekly for 4 weeks

Intervention Type: DRUG

interferon-a-2a

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

Intervention Type: DRUG

Other Intervention Names

MabThera; Rituxan; Roferon-A

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nordic Lymphoma Group

NETWORK

Sponsor Role: collaborator

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_CHAIR

Hoffmann-La Roche

Locations

Copenhagen, , Denmark

Hillerød, , Denmark

Roskilde, , Denmark

Bergen, , Norway

Oslo, , Norway

Oslo, , Norway

Stavanger, , Norway

Tromsø, , Norway

Trondheim, , Norway

Eskilstuna, , Sweden

Falun, , Sweden

Gothenburg, , Sweden

Halmstad, , Sweden

Huddinge, , Sweden

Jönköping, , Sweden

Karlstad, , Sweden

Kristianstad, , Sweden

Linköping, , Sweden

Luleå, , Sweden

Lund, , Sweden

Malmo, , Sweden

Örebro, , Sweden

Stockholm, , Sweden

Stockholm, , Sweden

Sundsvall, , Sweden

Uddevalla, , Sweden

Umeå, , Sweden

Uppsala, , Sweden

Vaxjo, , Sweden

Västerås, , Sweden

Visby, , Sweden

Countries

Denmark; Norway; Sweden

References

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.

Reference Type: DERIVED

PMID: 25686644 (View on PubMed)

Other Identifiers

ML16865

Identifier Type: -

Identifier Source: org_study_id