Trial of Endostar Combined With CHOPT for T Cell Lymphoma

• Status: Unknown status
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital
• Collaborator: Simcere Pharmaceutical Co., Ltd
• Treatments: Endostar protein; Endostatins

Criteria

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