Trial of Endostar Combined With CHOPT for T Cell Lymphoma

November 2, 2015 updated by: Tianjin Medical University Cancer Institute and Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin
      • Tianjin, Tianjin, China, 300060
        • Tianjin Medical University Cancer Institute and Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Endostatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
safety of Endostar combined with CHOPT chemotherapy
Time Frame: 1 year
Number of participants with adverse events as a measure of safety
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Medical University Cancer Institute and Hospital

Collaborators

Simcere Pharmaceutical Co., Ltd

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Anticipated)

November 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 11, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (Estimate)

September 7, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2367240

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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