EUCTR2006-005520-16-SK进行中（未招募）1 期
A multi-center, randomized, double-blind, placebo-controlled phase III trial omparing the efficacy of bevacizumab in combination with rituximab and CHOP (RA-CHOP) versus rituximab and CHOP (R-CHOP) in previously untreated patients with CD20-positive diffuse large B-cell lymphoma (DLBCL) - MAI
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,060
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
- •Written informed consent
- •Age = 18 years
- •CD20-positive diffuse large B-cell lymphoma (DLBCL) or histologic variants (e.g.,
- •centroblastic, immuno¬blastic, T-cell/histocyte-rich, anaplastic large B cell, plasmablastic lymphoma, lymphomatoid granulomatosis type) under the WHO
- •classification
- •Low-intermediate, high-intermediate, or high risk disease according to the IPI score and/or bulky disease (largest diameter = 7.5 cm) regardless of IPI score
- •No prior therapy for DLBCL
- •Bi-dimensionally measurable disease
- •Performance status (ECOG) 0-2
- •Cardiac ejection fraction = 50 % as measured by MUGA or 2D-ECHO without clinically significant abnormalities
- •Adequate hematological function: hemoglobin = 9g/dL absolute neutrophil count = 1,500/µL and platelet count = 100,000/µL, unless abnormalities are due to bone marrow involvement by lymphoma
- •Adequate renal function as documented by:
- •a serum creatinine level < 2 mg/dL (177 µmol/L)
- •urine dipstick for proteinuria < 2+. If urine dipstick is = 2+, 24-hrs urine collection must demonstrate = 1 g protein secretion in 24 hours
- •Adequate hepatic function (total bilirubin < 1.5 x ULN, transaminases [AST and ALT]
- •< 2.5 x ULN [or < 5 x ULN in the presence of DLBCL involvement of the liver])
- •The use of full-dose oral or parenteral anticoagulants is permitted as long as the INR, or other monitoring test as appropriate, is within therapeutic limits and the patient has been on a stable dose of anticoagulants for at least 2 weeks at the time of randomization. Patients not receiving anticoagulant medication must have an INR = 1.5 and a PTT = 1.5 x ULN within 7 days of randomization.
- •Life expectancy > 6 months
- •A negative serum pregnancy test one week prior to treatment must be available both for pre-menopausal women and for women who are < 2 years after the onset of menopause, or within 14 days with a confirmatory urine pregnancy test within 1 week prior to study treatment start
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Transformed NHL or types of NHL other than DLBCL and its subtypes according to WHO classification
- •Prior therapy for DLBCL
- •CNS involvement by lymphoma or any evidence of spinal cord compression. Brain
- •CT/MRI is only mandatory (within 4 weeks prior to randomization) in case of clinical
- •suspicion of CNS involvement by lymphoma.
- •CT-scan based evidence of tumor invading major blood vessels (putting patients at risk for bleeding during study treatment)
- •Gastrointestinal tract involvement by lymphoma. Note that endoscopy is not a
- •mandated pre-study procedure for all patients.
- •Seropositivity for Hepatitis B unless clearly due to vaccination (Hepatitis B testing is not mandatory, but highly recommended)
- •Known HIV infection (HIV testing is not mandatory in this study)
- •Active viral, bacterial or fungal infection
- •History of solid organ transplantation
- •Pregnant or nursing females
- •Men and women of childbearing potential
- •(< 2 years after last menstruation) not using effective means of contraception (oral
- •contraceptives, intrauterine contraceptive device, barrier method of contraception in
- •conjunction with spermicidal jelly, or surgically sterile)
- •Prior malignancy (except adequately treated basal cell carcinoma of the skin, in situ
- •cervical cancer, or any other cancer for which the patient has been in remission for at least 5 years)
- •Known hypersensitivity to any of the study drugs or its ingredients (i.e., hypersensitivity to Polysorbate 20, CHO cell products, or recombinant human antibodies)
- •Uncontrolled seizures requiring permanent anticonvulsant therapy
- •Severe chronic obstructive pulmonary disease with hypoxemia
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension, CVA/stroke (= 6 months prior to randomization),
- •myocardial infarction (= 6 months prior to randomization), unstable angina
- •(= NYHA Grade IV), thrombosis within 6 months before enrolment, NYHA = Grade II
- •CHF, or serious cardiac arrhythmia requiring ongoing medication
- •Clinically significant, active peripheral vascular disease, serious non-healing
- •wound/ulcer, bone fracture, bleeding diathesis (history or evidence of inherited bleeding diathesis) or coagulopathy
- •Major surgery, open biopsy or trauma within 28 days before enrolment (lymph node
- •biopsies are not considered major surgery), or the need for major surgery during the course of study treatment
- •History of active ulcer (within 1 year prior to randomization), abdominal fistula,
- •gastrointestinal perforation, or intra-abdominal abscess or concurrent therapy for
- •treatment/prevention of ulcer
- •Current or recent (within the 30 days prior to starting study treatment) treatment with another investigational drug or participation in another investigational therapeutic study
- •Evidence of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that
- •contraindicates use of an investigational drug, or patient at high risk from treatment
- •complications
- •Any co-existing medical or psychological condition that would compromise ability to
- •give informed consent
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