Endostar Combined With CHOP Regimen as First Line Chemotherapy for Peripheral T Cell Lymphoma

Study Overview
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Brief Summary
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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 (VEGF) effects on angiogenesis and the integrity of tumor vasculature, autocrine VEGF-receptor (VEGF-R)-mediated signaling may play a role in lymphoma. Microvessel density, a measure of angiogenesis, is highest in peripheral T-cell lymphomas (PTCL), followed by diffuse large B-cell (DLBCL) and intra-follicular follicular lymphoma (FL).

Detailed Description
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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 VEGF and prognosis in peripheral T cell lymphoma,unspecified(PTCL-U) and angioimmunoblastic T-cellLymphoma(AILT).Methods 15 cases of PTCL were enrolled in this study.Immunohistochemical staining was performed by EnVision method using antibodies VEGF.

Official Title
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Phase 2 Study of Endostar Combined With CHOP Regimen as the First Line Chemotherapy for Untreated Peripheral T Cell Lymphoma

Conditions
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T Cell Lymphoma

Intervention / Treatment
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* Drug: endostar and CHOP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>endostar combined with CHOP regimen | Drug: endostar and CHOP<br>* endostar, 7.5m g/m2, intravenous, Day 2-15, repeat every 3 weeks CHOP: Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone<br>* Other names: endostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy include overall response rate, disease free survival and overall survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of endostar combined with CHOP |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral T cell lymphoma, chemotherapy, anti-angiogeneses