A randomized, controlled, double-blind Phase III trial to compare theefficacy, safety and pharmacokinetics of GP2013 plus Cyclophosphamide,Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine,Prednisone, followed by GP2013 or MabThera® maintenance therapy inpatients with previously untreated, advanced stage follicular lymphoma.

HEXAL AG (a Sandoz company)0 个研究点目标入组 618 人开始时间: 2011年8月31日最近更新: 2016年2月1日

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 618

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•following criteria:
•1. Patient with previously untreated advanced stage, CD20-positive FL:
•a. Ann Arbor classification stage III/IV;
•b. WHO histologic grade 1, 2 or 3a, as confirmed by central
•pathological testing; and
•c. Require therapy for FL as per local guidelines or in the opinion of
•the treating physician.
•2. Patient age = 18 years.
•3. Patient with at least one measurable lesion (accurately measurable in
•at least 2 perpendicular dimensions);
•a. at least 1 measurable nodal lesion > 20 mm in the long axis; OR
•b. at least 1 measurable extranodal lesion with both long and short
•axes = 10 mm.
•4. Patient with ECOG performance status 0, 1 or 2.
•5. Patient with adequate cardiac function defined as cardiac ejection
•fraction = 45% as measured by ECHO or MUGA, without clinically
•significant abnormalities.
•6. Patient with the following laboratory values obtained during
•Screening (up to 28 days before randomization):
•a. hemoglobin = 10g/dL (unless abnormalities are due to
•histologically proven bone marrow involvement by lymphoma);
•b. absolute neutrophil count (ANC) = 1.5 x 10^9/L (unless
•abnormalities are due to histologically proven bone marrow involvement
•by lymphoma);
•c. platelet count = 100 x 10^9/L (unless abnormalities are due to
•histologically proven bone marrow involvement by lymphoma);
•d. total bilirubin < 1.5 x ULN (upper limit of normal) (if Gilbert-
•Meulengracht syndrome is present, up to 2.0 x ULN is allowed);
•e. transaminases < 2.5 x ULN;
•f. serum creatinine level < 2 x ULN or calculated creatinine clearance
•> 50 mL/min;
•g. negative serologic or virologic markers for active or latent hepatitis
•B and hepatitis C infections.
•7. Sexually active males who accept to use a condom during intercourse
•while taking the drug and for 12 months after stopping treatment as
•they should not father a child in this period. A condom is required to be
•used also by vasectomised men (as well as during intercourse with a
•male partner) in order to prevent delivery of the drug via seminal fluid.
•8. a) Women of child-bearing potential, defined as all women
•physiologically capable of becoming pregnant, including women whose
•career, lifestyle, or sexual orientation precludes intercourse with a male
•partner and women whose partner have been sterilized by vasectomy or
•other means, who accept to use a highly effective method of birth
•control while taking study drug and for 12 months after stopping
•b) Women who are considered post-menopausal and not of child bearing
•potential i.e. if they have had 6 months of natural (spontaneous)
•amenorrhea with an appropriate clinical profile (e.g. age appropriate,
•history of vasomotor symptoms) or have had surgical bilateral
•oophorectomy (with or without hysterectomy) or tubal ligation at least
•six weeks ago (in the case of oophorectomy alone, only when the
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排除标准

•1. Patient with Grade 3b (aggressive) FL or any histology other than FL
•grade 1, 2 or 3a.
•2. Patient with histological evidence of transformation to high grade or
•diffuse large B-cell lymphoma.
•3. Patient who has previously received any prior therapy for lymphoma, e.g. cytostatic or cytotoxic agents, antibodies, anti-lymphoma
•vaccination, experimental treatments and radiotherapy, except who received involved field radiation 4 weeks prior to Cycle 1 Day 1, of up to two lesions that will not be used to evaluate disease progression.
•4. Evidence of significant leukemic disease defined as >10 x 109 /L
•circulating CD20+ lymphoma cells.
•5. Patient with clinical evidence of central nervous system (CNS)
•involvement by lymphoma or any evidence of spinal cord compression by
•6. Patient with evidence of any uncontrolled, acute or chronic active
•infection (viral, bacterial, including tuberculosis or fungal).
•7. Patient receiving chronic (>3 months), high dose (> 20 mg of
•prednisone or > approximately 3 mg of dexamethasone per day or
•equivalent doses of other steroid medications) of systemic
•corticosteroids.
•8. Patient with any malignancy within 5 years prior to date of
•randomization, with the exception of adequately treated in situ
•carcinoma of the cervix uteri, basal or squamous cell carcinoma or
•nonmelanomatous skin cancer.
•9. Patient with a known hypersensitivity to any of the study treatment
•ingredients e.g. to recombinant human antibodies.
•10. Patient with concurrent serious illnesses, uncontrolled medical
•conditions, or other medical history including clinically relevant
•abnormal laboratory results, which in the investigator's opinion would
•be interfere with a patient's participation in the study, or with the
•interpretation of study results:
•a. uncontrolled neurological disease (e.g. recurrent seizures despite
•existing anticonvulsant therapy);
•b. neuropathy = grade 1, neuromuscular disease;
•c. severe disturbance of liver function;
•d. severe constipation;
•e. cystitis or other ongoing infections;
•f. disturbance of micturition;
•g. severe chronic obstructive pulmonary disease with clinically
•manifest hypoxemia;
•h. uncontrolled hypertension (defined as systolic BP > 160 mm Hg or
•diastolic > 100 mm Hg);
•i. history of stroke or cerebral ischemia (within 6 months prior to
•screening);
•j. history of myocardial infarction or other clinically significant
•myocardial disease (within 6 months prior to screening) or unstable
•angina (= NYHA Grade II);
•k. known infection with HIV or any other severe immunecompromised
•state according to patient history (if required by local
•regulations or clinical practice guidelines, patient may be tested during
•the screening period to confirm HIV status);
•l. evidence of ongoing drug or alcohol abuse within the last 6 months
•before screening;
•m . active tuberculosis. Patients with evidence of latent tuberculosis
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研究者

发起方

HEXAL AG (a Sandoz company)

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