This trial is active, not recruiting.

Condition t cell lymphoma
Treatment endostar and chopt
Phase phase 2
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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment
CHOPT chemotherapy plus Endostar
endostar and chopt Endostatin
Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone

Primary Outcomes

efficacy including overall response rate, progression free survival and overall survival
time frame: 1 year

Secondary Outcomes

safety of Endostar combined with CHOPT chemotherapy
time frame: 1 year

Eligibility Criteria

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

Additional Information

Official title Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Principal investigator Huaqing wang, MD
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Tianjin Medical University Cancer Institute and Hospital.