PER-015-08已完成未知
Bevacizumab and Combination Chemotherapy in Treating Patients With Peripheral T-Cell Lymphoma or Natural Killer Cell Neoplasms
EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),0 个研究点目标入组 0 人开始时间: 2008年5月29日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
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
入选标准
- •Diagnosis of peripheral T-cell or natural killer cell neoplasm
- •o Any stage disease allowed
- •o HTLV-positive tumors allowed
- •At least one objective measurable disease parameter. Abnormal positron emission tomography scans are not considered evidence of measurable disease unless results are confirmed by CT scan or other appropriate imaging techniques
- •Age 18 and over
- •ECOG Performance status 0-2
- •Absolute neutrophil count ≥ 1,000/mm^3(500/mm^3 if due to bone marrow involvement with lymphoma)
- •Platelet count ≥ 100,000/mm^3(50,000/mm^3 if due to bone marrow involvement with lymphoma)
- •Bilirubin ≤ 2.0 mg/dL (≤ 3 times upper limit of normal [ULN] if due to hepatic involvement with lymphoma)
- •AST ≤ 2 times ULN (5 times ULN if due to hepatic involvement with lymphoma)
- •PT, INR, and PTT ≤ 1.5 times normal
- •Creatinine ≤ 2.0 mg/dL
- •Urinary protein:creatinine ratio ≤ 1
- •History of deep venous thrombosis allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry
- •LVEF ≥ 50%
- •History of pulmonary embolism allowed provided patient is on a stable dose of anticoagulants for at least 2 weeks prior to study entry
- •One prior cycle of CHOP for PTCL allowed
- •More than 4 weeks since prior major invasive surgery or open biopsy
- •At least 7 days since prior minor surgery. Peripheral lymph node core biopsy, bone marrow biopsy, fine needle aspiration, skin biopsy, or central line placement are not considered minor surgical procedures
- •More than 7 days since prior and no concurrent anti-platelet drugs (e.g., ticlopidine, clopidogrel, or cilostazol) except aspirin or other nonsteroidal anti-inflammatory drugs
- •Concurrent anticoagulants allowed provided patient is on a stable dose
排除标准
- •Anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma. ALK-negative T-cell large cell lymphoma allowed
- •Cutaneous T-cell lymphoma
- •History of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement
- •Evidence of bleeding diathesis or coagulopathy
- •Cerebrovascular accident within the past 6 months
- •Myocardial infarction within the past 6 months
- •Unstable angina within the past 6 months
- •New York Heart Association class II-IV congestive heart failure
- •Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 150 mm Hg or diastolic BP > 100 mm Hg)
- •Other clinically significant cardiovascular or peripheral vascular disease
- •Abdominal fistula within the past 6 months
- •Gastrointestinal perforation within the past 6 months
- •Intra-abdominal abscess within the past 6 months
- •Concurrent major surgery
- •Pregnant or nursing. Female patients must have negative pregnancy test. Fertile patients must use effective contraception
- •History of active seizures
- •Significant traumatic injury within the past 4 weeks
- •Non-healing ulcer (unless involved with lymphoma)
- •Bone fracture
- •Active infection requiring parenteral antibiotics
- •HIV positivity
- •Other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin
研究者
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