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Trial of Endostar Combined With CHOPT for T Cell Lymphoma

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2011 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital Identifier:
First received: July 11, 2011
Last updated: November 2, 2015
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 ]
    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 ]
    Number of participants with adverse events as a measure of safety

Estimated Enrollment: 30
Study Start Date: June 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: November 2015 (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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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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

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: November 2, 2015

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 May 23, 2017