Back to resultsTrial of Endostar Combined With CHOPT for T Cell Lymphoma
Primary Purpose
T Cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Endostar and CHOPT
Sponsored by
About this trial
This is an interventional treatment trial for T Cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Male and female aged 18 to 70 years old.
- Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
- At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
- Eastern Cooperative Oncology Group status 0-2
- White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
- 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:
- No active central nervous system lymphoma or brain tumor
- Suppurative inflammation,Chronic infection
- Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
- psychiatric history
- Primary cutaneous T cell lymphoma
- Pregnant or lactating women
- Concurrent treatment with another investigational agent
- Accept radiotherapy
Sites / Locations
- Tianjin Medical University Cancer Institute and Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Endostar
Arm Description
CHOPT chemotherapy plus Endostar
Outcomes
Primary Outcome Measures
efficacy including overall response rate, progression free survival and overall survival
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
safety of Endostar combined with CHOPT chemotherapy
Number of participants with adverse events as a measure of safety
Full Information
NCT ID
NCT01430013
First Posted
July 11, 2011
Last Updated
November 2, 2015
Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Simcere Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01430013
Brief Title
Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Official Title
Phase II Trial of Endostar Combined With CHOPT for T Cell Lymphoma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2011 (undefined)
Primary Completion Date
November 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Simcere Pharmaceutical Co., Ltd
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the efficacy and safety of Endostar combined with CHOPT in the treatment of T cell lymphoma.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
T Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Endostar
Arm Type
Experimental
Arm Description
CHOPT chemotherapy plus Endostar
Intervention Type
Drug
Intervention Name(s)
Endostar and CHOPT
Other Intervention Name(s)
Endostatin
Intervention Description
Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone
Primary Outcome Measure Information:
Title
efficacy including overall response rate, progression free survival and overall survival
Description
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety of Endostar combined with CHOPT chemotherapy
Description
Number of participants with adverse events as a measure of safety
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male and female aged 18 to 70 years old.
Diagnosis of T cell lymphoma according to WHO Classification, without antitumor therapy
At least 1 measurable tumor mass (greater than 1.5cm in the longest dimension and greater than 1.0 in the short axis)
Eastern Cooperative Oncology Group status 0-2
White blood cell≥4.0×109cells/L; Absolute neutrophil count (ANC) ≥1.5×109cells /L; Platelets≥100×109cells/L
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:
No active central nervous system lymphoma or brain tumor
Suppurative inflammation,Chronic infection
Severe heart disease, conclusion: congestive heart failure; uncontrolled cardiac arrhythmia; myocardial infarction; refractory hypertension
psychiatric history
Primary cutaneous T cell lymphoma
Pregnant or lactating women
Concurrent treatment with another investigational agent
Accept radiotherapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huaqing wang, MD
Organizational Affiliation
Tianjin Medical University Cancer Institue and Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tianjin Medical University Cancer Institute and Hospital
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Trial of Endostar Combined With CHOPT for T Cell Lymphoma
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