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

Phase 2
18 Years
75 Years
Open (Enrolling)
T Cell Lymphoma

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Trial Information

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

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.

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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Junning Cao, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Member of Fudan University Cancer Hospital


China: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

September 2011

Related Keywords:

  • T Cell Lymphoma
  • peripheral T cell lymphoma
  • chemotherapy
  • anti-angiogeneses
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral