EUCTR2010-023407-95-IT
Active, not recruiting
Phase 1
A randomized study comparing maintenance therapy withsubcutaneous rituximab continued until progression with observation only in patients with relapsed or refractory, indolent non-Hodgkin’s lymphoma who completed and responded to rituximab-based immunochemotherapy induction and initial 2-year rituximab maintenance therapy administered subcutaneously.
ConditionsPatients with relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system, or other not further classified low malignant lymphoma by immunohistochemistry.MedDRA version: 14.1Level: PTClassification code 10061170Term: Follicle centre lymphoma, follicular grade I, II, IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
DrugsMabThera
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with relapsed or refractory CD20+ follicular non-Hodgkin's lymphoma (NHL) Grade 1, 2 or 3a, or other CD20+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma), according to the WHO classification system, or other not further classified low malignant lymphoma by immunohistochemistry.
- Sponsor
- ROCHE
- Enrollment
- 692
- Status
- Active, not recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\- Age \= 18 years. \- Histologically confirmed, CD20\+ follicular NHL Grade 1, 2 or 3a, orother CD20\+ indolent NHL (Waldenström's macroglobulinemia or lymphoplasmacytic lymphoma, marginal zone lymphoma) according to the WHO classification system, other not further classified low malignant lymphoma by immunohistochemistry. \- Patients must have received and must have relapsed or been refractory to one or more lines of adequate induction therapy prior to enrolment, including at least one line consisting of immunotherapy and/or chemotherapy. • Eastern Cooperative Oncology Group (ECOG) performance status \= 2\.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 420
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 280
Exclusion Criteria
- •\- Transformation to high\-grade lymphoma. \- Patients with aggressive lymphoma (e.g. mantle cell lymphoma). \- Presence or history of central nervous system (CNS) lymphomatous disease (e.g., CNS lymphoma or lymphomatous meningitis). \- Other malignancy within 5 years prior to enrolment, with the following exceptions (as long as curatively treated): carcinoma in situ of the cervix, squamous cell carcinoma of the skin, or basal cell skin cancer. Cervical carcinoma stage 1B or less, breast cancer in situ, or localized prostate cancer stage T1c or less may be considered, provided that the patient was treated with curative intent and has been relapse\- and metastasis\-free for at least 2 years prior to enrolment. \- Inadequate hepatic or renal function prior to the first rituximab induction dose. \- Known human immunodeficiency virus (HIV) infection.
Outcomes
Primary Outcomes
Not specified
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