Trial of Endostar Combined With CHOPT for T Cell Lymphoma

This study is ongoing, but not recruiting participants.
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital Identifier:
First received: July 11, 2011
Last updated: April 20, 2014
Last verified: September 2011

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

Condition Intervention Phase
T Cell Lymphoma
Drug: Endostar and CHOPT
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma

Resource links provided by NLM:

Further study details as provided by Tianjin Medical University Cancer Institute and Hospital:

Primary Outcome Measures:
  • efficacy including overall response rate, progression free survival and overall survival [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    According to International Workshop Criteria, the number of participants with complete remission, partial remission and stable disease as a measure of free survival and overall survival of the participants are the second measure of efficacy

Secondary Outcome Measures:
  • safety of Endostar combined with CHOPT chemotherapy [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    Number of participants with adverse events as a measure of safety

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Endostar
CHOPT chemotherapy plus Endostar
Drug: Endostar and CHOPT
Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone
Other Name: Endostatin


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Please refer to this study by its identifier: NCT01430013

China, Tianjin
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin, China, 300060
Sponsors and Collaborators
Tianjin Medical University Cancer Institute and Hospital
Simcere Pharmaceutical Co., Ltd
Principal Investigator: Huaqing wang, MD Tianjin Medical University Cancer Institue and Hospital
  More Information

No publications provided

Responsible Party: Tianjin Medical University Cancer Institute and Hospital Identifier: NCT01430013     History of Changes
Other Study ID Numbers: 2367240
Study First Received: July 11, 2011
Last Updated: April 20, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lymphoma, T-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin processed this record on April 21, 2014