NL-OMON44911已完成3 期
A Randomized, Controlled, Double-Blind Phase III Trial to Compare the Efficacy, Safety and Pharmacokinetics of GP2013 plus CVP vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone vs. MabThera® plus Cyclophosphamide, Vincristine, Prednisone, followed by GP2013 or MabThera® Maintenance Therapy in Patients with Previously Untreated, Advanced Stage Follicular Lymphoma - GP13-301
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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 measureable 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 2D-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 109/L (unless abnormalities are due to histologically proven bone marrow involvement by lymphoma);
- •c. platelet count * 100 x 109/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 of latent hepatitis B and hepatitis C infections.
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 lymphoma.
- •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 non-melanomatous 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 likely to 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 (dyspnea > grade 1);
- •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 randomization);
- •j. history of myocardial infarction or other clinically significant myocardial disease (within 6 months prior to screening) or unstable angina (* NYHA Grade II);
- •k. inadequate cardiac function defined as cardiac ejection fraction < 45% as measured by 2D-ECHO or MUGA;
- •l. known infection with HIV or any other severe immune-compromised 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);
- •m. evidence of ongoing drug or alcohol abuse within the last 6 months before screening;
- •n. Active tuberculosis. Patients with evidence of latent tuberculosis as per results of the tuberculosis screening test and further follow-up may enter the study after evaluation by an appropriate specialist and after sufficient treatment has been initiated according to local medical practice.
- •11. Patient has had major surgery, open biopsy or trauma within 4 weeks prior to date of screening (lymph node biopsy is not regarded as major surge
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