Trial of Endostar Combined With CHOPT for T Cell Lymphoma
This trial is active, not recruiting.
|Condition||t cell lymphoma|
|Treatment||endostar and chopt|
|Sponsor||Tianjin Medical University Cancer Institute and Hospital|
|Collaborator||Simcere Pharmaceutical Co., Ltd|
|Start date||June 2011|
|End date||November 2015|
|Trial size||30 participants|
|Trial identifier||NCT01430013, 2367240|
To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.
|Intervention model||single group assignment|
CHOPT chemotherapy plus Endostar
efficacy including overall response rate, progression free survival and overall survival
time frame: 1 year
safety of Endostar combined with CHOPT chemotherapy
time frame: 1 year
Male or female participants from 18 years up to 70 years old.
Inclusion Criteria: 1. Male and female aged 18 to 70 years old. 2. Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy 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; Platelets≥100×109cells/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
|Official title||Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma|
|Principal investigator||Huaqing wang, MD|
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