Status:
UNKNOWN
Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma
Lead Sponsor:
Fudan University
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The role of angiogenesis has been less clear in lymphoma than in solid tumors, in part related to the heterogeneity of disease and technical issues. In addition to vascular endothelial growth factor (...
Detailed Description
To investigate efficacy and safety of endostar combined with CHOP regimen as first line treatment for peripheral T cell lymphoma.The second subject is to clarify the association between expression of ...
Eligibility Criteria
Inclusion
- Disease Characteristics:
- Diagnosis of peripheral T-cell:
- Any stage disease allowed
- At least 1 objective measurable disease parameter
- No anaplastic lymphoma kinase (ALK)-positive T-cell large cell lymphoma
- ALK-negative T-cell large cell lymphoma allowed
- No cutaneous T-cell lymphoma
- No sezary syndrome
- No NK/T cell lymphoma
- No history of or current radiographic evidence of CNS metastasis, including previously treated, resected, or asymptomatic brain lesions or leptomeningeal involvement
- Patient Characteristics:
- Age:
- 18 -75 years
- Performance status:
- ECOG 0-2
- Life expectancy:
- No less than 12 weeks
- Hematopoietic:
- Absolute neutrophil count ≥ 1,500/mm\^3
- Hemoglobulin ≥ 80\*10\^12/L
- Platelet count ≥ 100,000/mm\^3
- No evidence of bleeding diathesis or coagulopathy
- Hepatic:
- Bilirubin ≤ 1.5 mg/dL
- AST ≤ 2.5 times ULN
- PT, INR, and PTT ≤ 1.5 times normal
- Renal:
- Creatinine ≤ 1.5 times normal
- Cardiovascular:
- No cerebrovascular accident within the past 6 months
- No myocardial infarction within the past 6 months
- No unstable angina within the past 6 months
- No New York Heart Association class II-IV congestive heart failure
- No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] \> 150 mm Hg or diastolic BP \> 100 mm Hg)
- No other clinically significant cardiovascular or peripheral vascular disease
- LVEF is normal
- Other:
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No history of active seizures
- No non-healing ulcer (unless involved with lymphoma)
- No active infection requiring parenteral antibiotics
- No known HIV positivity
- No other active malignancy within the past 6 months except carcinoma in situ of the cervix or basal cell carcinoma of the skin
- PRIOR CONCURRENT THERAPY:
- Biologic therapy:
- Not specified
- Chemotherapy:
- No prior chemotherapy was allowed
- Surgery:
- More than 4 weeks since prior major invasive surgery or open biopsy
- At least 7 days since prior minor surgery
- No concurrent major surgery
Exclusion
- Prior treatment included chemotherapy and radiotherapy
- With the following risk factors: Uncontrolled or severe cardiovascular disease (e.g., myocardial infarction within the past 6 months, congestive heart failure treated with medications, or uncontrolled hypertension)
- Pregnant or nursing
- Other currently active malignancy except nonmelanoma skin cancer
- Uncontrolled or severe bleeding,diarrhea,intestinal obstruction
- Hypersensitivity to albumen
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2011
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00974324
Start Date
August 1 2009
End Date
September 1 2011
Last Update
September 15 2010
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032