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Trial of Endostar Combined With CHOPT for T Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT01430013
Recruitment Status : Unknown
Verified September 2011 by Tianjin Medical University Cancer Institute and Hospital.
Recruitment status was:  Active, not recruiting
First Posted : September 7, 2011
Last Update Posted : November 4, 2015
Sponsor:
Collaborator:
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
T Cell Lymphoma Drug: Endostar and CHOPT Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Study Start Date : June 2011
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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 efficacy.progressive free survival and overall survival of the participants are the second measure of efficacy


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



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01430013


Locations
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
Investigators
Principal Investigator: Huaqing wang, MD Tianjin Medical University Cancer Institue and Hospital

Responsible Party: Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier: NCT01430013     History of Changes
Other Study ID Numbers: 2367240
First Posted: September 7, 2011    Key Record Dates
Last Update Posted: November 4, 2015
Last Verified: September 2011

Additional relevant MeSH terms:
Lymphoma
Lymphoma, T-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin