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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


Phase 3
18 Years
N/A
Not Enrolling
Both
Lymphoma

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Time to treatment failure

Outcome Time Frame:

approximately 3 years

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Chair

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Sweden: Medical Products Agency

Study ID:

ML16865

NCT ID:

NCT01609010

Start Date:

October 2002

Completion Date:

July 2011

Related Keywords:

  • Lymphoma
  • Lymphoma

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