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

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Brief Title

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

Official Title

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

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 (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

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 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.

Study Phase

Phase 2

Study Type


Primary Outcome

efficacy include overall response rate, disease free survival and overall survival

Secondary Outcome

 safety of endostar combined with CHOP


T Cell Lymphoma


endostar and CHOP

Study Arms / Comparison Groups

Description:  endostar combined with CHOP regimen


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

August 2009

Completion Date

September 2011

Primary Completion Date

September 2010

Eligibility Criteria

        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

          -  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

                    -  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


               -  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




18 Years - 75 Years

Accepts Healthy Volunteers



Junning Cao, MD, 86(021)64175590, [email protected]

Location Countries


Location Countries


Administrative Informations



Organization ID


Study Sponsor

Fudan University

Study Sponsor

Junning Cao, MD, Principal Investigator, Member of Fudan University Cancer Hospital

Verification Date

September 2010