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: 2011年5月17日最近更新: 2022年3月2日

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 other prior malignancy with the exception of curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or cacinoma in situ of the cervix at any time prior to the study. Other cancers not specified above wich have been curatively treated by surgary alone and from which the subject is disease-free for =5years without further treatment
•- 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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