A MULTICENTER, PHASE III, OPEN-LABEL,RANDOMIZED STUDY IN PREVIOUSLYUNTREATED PATIENTS WITH ADVANCEDINDOLENT NON-HODGKIN'S LYMPHOMAEVALUATING THE BENEFIT OF GA101(RO5072759) PLUS CHEMOTHERAPYCOMPARED WITH RITUXIMAB PLUSCHEMOTHERAPY FOLLOWED BY GA101 ORRITUXIMAB MAINTENANCE THERAPY INRESPONDERS - GALLIUM

F. Hoffmann-La Roche Ltd.0 个研究点目标入组 1,401 人开始时间: 2013年2月4日最近更新: 2021年10月8日

适应症

试验速览

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•- Adult patients, >/= 18 years of age
•- CD20-positive indolent B-cell non-Hodgkin's lymphoma (follicular lymphoma or splenic, nodal or extranodal marginal zone lymphoma)
•- Stage III or IV disease, or Stage II bulky disease
•- At least one bi-dimensionally measurable lesion (>2 cm in its largest dimension by CT scan or MRI)
•- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
•- Adequate hematologic function
•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 504
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 252

•- Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
•- Grade 3b follicular lymphoma, small lymphocytic lymphoma or Waldenström's macroglobulinaemia
•- Ann Arbor Stage I disease
•- History of severe allergic or anaphylactic reactions to monoclonal antibody therapy, known hypersensitivity to any of the study drugs or sensitivity to murine products, or history of sensitivity to mannitol
•- For patients with follicular lymphoma: prior treatment for non-Hodgkin's lymphoma with chemotherapy, immunotherapy, or radiotherapy
•- For patients with non-follicular lymphoma: prior treatment with chemotherapy or immunotherapy
•- History of prior malignancy with the exception of curatively treated basal or squamous cell carcinoma of the skin and low-grade in situ carcinoma of the cervix
•- Known active infection, or major episode of infection within 4 week prior to the start of Cycle 1
•- Positive for HIV, HTLV1, hepatitis C or chronic hepatitis B
•- Patients with a history of confirmed PML

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