Trial of Endostar Combined With CHOPT for T Cell Lymphoma

Tianjin Medical University

Status and phase: Unknown; Phase 2

Conditions: T Cell Lymphoma

Treatments: Drug: Endostar and CHOPT

Study type: Interventional

Funder types: Other

Identifiers

NCT01430013

2367240

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endostar

Experimental group

Description:

CHOPT chemotherapy plus Endostar

Treatment:

Drug: Endostar and CHOPT