Trial of Endostar Combined With CHOPT for T Cell Lymphoma
This study is ongoing, but not recruiting participants.
Sponsor:
Tianjin Medical University Cancer Institute and Hospital
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
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Purpose
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 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 [ 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 2014 |
| Estimated Primary Completion Date: | June 2013 (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
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
No publications provided
| Responsible Party: | Tianjin Medical University Cancer Institute and Hospital |
| ClinicalTrials.gov Identifier: | NCT01430013 History of Changes |
| Other Study ID Numbers: | 2367240 |
| Study First Received: | July 11, 2011 |
| Last Updated: | January 22, 2013 |
| Health Authority: | China: Food and Drug Administration |
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 |
ClinicalTrials.gov processed this record on May 21, 2013