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Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma

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

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Trial Information

Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma

Inclusion Criteria:

1. Male and female aged 18 to 70 years old.

2. Diagnosis of T cell lymphoma according to WHO Classification, without antitumor

3. At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and
greater than 1.0 in the short axis)

4. Eastern Cooperative Oncology Group status 0-2

5. White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L;

6. Alanine transaminase (ALT) ≤2×upper limit of normal(ULN); Aspartate transaminase
(AST) ≤2×ULN; Total Bilirubin≤1.5×ULN; Creatinine in normal range

Exclusion Criteria:

1. No active central nervous system lymphoma or brain tumor

2. Suppurative inflammation,Chronic infection

3. Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac
arrhythmia; myocardial infarction; refractory hypertension

4. psychiatric history

5. Primary cutaneous T cell lymphoma

6. Pregnant or lactating women

7. Concurrent treatment with another investigational agent

8. Accept radiotherapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

efficacy including overall response rate, progression free survival and overall survival

Outcome Description:

According to International Workshop Criteria, the number of participants with complete remission, partial remission and stable disease as a measure of free survival and overall survival of the participants are the second measure of efficacy

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Huaqing wang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Tianjin Medical University Cancer Institue and Hospital


China: Food and Drug Administration

Study ID:




Start Date:

June 2011

Completion Date:

June 2014

Related Keywords:

  • T Cell Lymphoma
  • Lymphoma
  • Lymphoma, T-Cell