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Trial of Endostar Combined With CHOPT for T Cell Lymphoma

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Simcere Pharmaceutical Co., Ltd
Information provided by (Responsible Party):
Tianjin Medical University Cancer Institute and Hospital
ClinicalTrials.gov Identifier:
NCT01430013
First received: July 11, 2011
Last updated: January 22, 2013
Last verified: September 2011
History of Changes

July 11, 2011
January 22, 2013
June 2011
June 2013   (final data collection date for primary outcome measure)
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 efficacy.progressive free survival and overall survival of the participants are the second measure of efficacy
Same as current
Complete list of historical versions of study NCT01430013 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma

To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
T Cell Lymphoma
Drug: Endostar and CHOPT
Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone
Other Name: Endostatin
Experimental: Endostar
CHOPT chemotherapy plus Endostar
Intervention: Drug: Endostar and CHOPT
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
30
June 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01430013
2367240
Yes
Tianjin Medical University Cancer Institute and Hospital
Tianjin Medical University Cancer Institute and Hospital
Simcere Pharmaceutical Co., Ltd
Principal Investigator: Huaqing wang, MD Tianjin Medical University Cancer Institue and Hospital
Tianjin Medical University Cancer Institute and Hospital
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP