Trial of Endostar Combined With CHOPT for T Cell Lymphoma

Phase 2

• Conditions: T Cell Lymphoma
• Interventions: Drug: Endostar and CHOPT

• Registration Number: NCT01430013
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-11
• Status Verified: 2011-09
• Study First Submitted QC: 2011-09-06
• Study First Posted: 2011-09-07
• Primary Completion: 2015-11
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endostar	Endostar and CHOPT	CHOPT chemotherapy plus Endostar

Primary Outcome Measures

Name	Time	Method
efficacy including overall response rate, progression free survival and overall survival	1 year	According to International Workshop Criteria, the number of participants with complete remission, partial remission and stable disease as a measure of efficacy.progressive free survival and overall survival of the participants are the second measure of efficacy

Secondary Outcome Measures

Name	Time	Method
safety of Endostar combined with CHOPT chemotherapy	1 year	Number of participants with adverse events as a measure of safety

Trial Locations

Locations (1)

Tianjin Medical University Cancer Institute and Hospital; 🇨🇳 Tianjin, Tianjin, China