Multicenter, open, phase III, randomized study in patients with advanced follicular lymphoma to evaluate the benefits of maintenance therapy with Rituximab (MabThera®) after induction of the response with chemotherapy plus Rituximab, compared to a treatment without maintenance therapy

PRODUCTOS ROCHE Q.F.S.A.,0 个研究点目标入组 10 人开始时间: 2005年7月25日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1) Follicular lymphoma grade 1, 2 or 3 confirmed by histology with
•a lymph node biopsy performed within 4 months before admission to the study.
•2) Detectable tumor mass on admission to the study, according to the GELF criteria.
•3) Adequate haematological function within 28 days prior to enrollment.
•4) Women who are not breastfeeding, who use effective methods of contraception, who are not pregnant and who agree not to become pregnant during participation in the study and during the following 12 months. Men who agree not to have children during participation in the study and during the following 12 months.
•5) Have previously signed a written informed consent.

•1) Transformation to high grade lymphoma.
•2) Follicular lymphoma grade 3b.
•3) Presence or history of illness in CNS.
•4) Patients treated regularly with corticosteroids during the last 4 weeks.
•5) Patients with previous or concomitant malignancies.
•6) Major surgery within 28 days prior to enrollment.
•7) Impaired renal function: serum creatinine> 2.0 mg / dl (197 pmoI / L)
•8) Altered liver function: Total bilirubin> 2.0 mg / dL (34 pmol / L), AST (SGOT)> 3 times the upper normal limit, except that these abnormalities are related to the lymphoma.
•9) Infection known to HIV or active HBV or HCV infection less than or equal to 4 weeks on admission.
•10) Serious underlying medical disorders, which may alter the patient´s ability to participate in the study.
•11) Life expectancy <6 months.
•12) Known sensitivity or allergy to murine products.
•13) Treatment within the framework of a clinical study within 30 days before entering the study.
•14) Any other co-existing medical or psychological disorder that impedes participation in the study or compromises the ability to provide informed consent.

发起方

PRODUCTOS ROCHE Q.F.S.A.,