Bevacizumab and CHOP (A-CHOP) in Combination for Patients With Peripheral T-Cell or Natural Killer Cell Neoplasms
- Conditions
- -C915 Adult T-cell lymphoma/leukaemia (HTLV-1-associated)Adult T-cell lymphoma/leukaemia (HTLV-1-associated)C915
- Registration Number
- PER-015-08
- Lead Sponsor
- EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG),
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
• 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
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method