Trial of Endostar Combined With CHOPT for T Cell Lymphoma

T Cell Lymphoma Clinical Trial

Official title:

Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01430013
• Other study ID #: 2367240
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 11, 2011
• Last updated: November 2, 2015
• Start date: June 2011
• Est. completion date: December 2015

Study information

• Verified date: September 2011
• Source: Tianjin Medical University Cancer Institute and Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• T Cell Lymphoma

Intervention

Drug:
• Endostar and CHOPT
Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone

Locations

Country	Name	City	State
China	Tianjin Medical University Cancer Institute and Hospital	Tianjin	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Medical University Cancer Institute and Hospital	Simcere Pharmaceutical Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy including overall response rate, progression free survival and overall survival	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	1 year	Yes
Secondary	safety of Endostar combined with CHOPT chemotherapy	Number of participants with adverse events as a measure of safety	1 year	Yes