Trial of Endostar Combined With CHOPT for T Cell Lymphoma

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01430013

Enrollment

Registered

2011-09-07

Start date

2011-06-30

Completion date

2015-12-31

Last updated

2015-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

T Cell Lymphoma

Brief summary

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

Interventions

DRUGEndostar and CHOPT

Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
safety of Endostar combined with CHOPT chemotherapy	1 year	Number of participants with adverse events as a measure of safety

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026