Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: April 20, 2014
Last verified: September 2011
  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 2015
Estimated Primary Completion Date: June 2014 (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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 20, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 24, 2014