Endostar Aggressive Treatment of Peripheral T-cell Lymphoma (PTCL) Phase II Clinical Study

August 6, 2015 updated by: Nanjing NingQi Medicine Science and Technology Co., Ltd.

The Efficacy and Safety Research of Endostar Combined With GDP to Treat Aggressive Peripheral T-cell Lymphoma (PTCL) in Phase II Clinical Study.

The aim of this study is to evaluate anti-tumor safety and efficacy of endostar®（Human recombinant endostatin injection）combined with traditional GDP （gemcitabine+dexamethasone+cis-platinum）chemotherapy for newly diagnosed or relapsed PTCL(aggressive peripheral T-cell lymphomas) patients in phase II clinical study.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Endostar is a conventional drug for treatment of advanced non-small cell lung cancer, nowadays,Endostar has been used in a variety of extra-pulmonary tumor treatment in clinical.Some basic experiments and clinical researchs confirm that Endostar can restitute the tumor stability after cyclophosphamide or rituximab treatment.

The aim of this study is to evaluate anti-tumor safety and efficacy of endostar for newly diagnosed or relapsed PTCL patients based on chemotherapy combined with conventional GDP.This is a multi-center, open, randomized-controlled, phase II clinical study.

Following a run-in period, approximately 60 subjects will be randomly assigned to conventional chemotherapy treatment group, endostar and conventional chemotherapy treatment group for 1 year. After the 1 year treatment period, subjects in two treatments arms will be followed for 1 year.

Study Type

Interventional

Enrollment (Anticipated)

60

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 Contact

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Nanjing City, Jiangsu, China, 210002
        • Recruiting
        • Jiangsu Province Tumor Hospital
        • Contact:
        • Contact:

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Newly diagnosed or relapsed PTCL patients by pathology, and / or cytology examination, which are required to receive chemotherapy;
  2. At least 1 single size measurable lesions, CT, MRI, Bultrasound scan or PET-CT scan shows more than 15mm；
  3. Physical condition is good: ECOG score between 0-2 points；
  4. The expected survival time is more than 3 months；
  5. Age 18 years or older,unlimited gender；

  6. Fit chemotherapy indications and basic requirements, including normal peripheral hemogram,no obvious abnormal function of heart, liver and kidney, normal ECG;no great trauma without healing；

    The test indicators must fit the following requirements:

    Cardiac ultrasound LVEF≥50%； Peripheral blood：WBC≥3.5×109/L，PLT≥70×109/L，Hb≥80g/L Renal function：Cr≤2.0×UNL（Upper limit of normal value） Liver function：BIL≤2.0×UNL，ALT/AST≤2.5×UNL

  7. No serious allergic reaction to biological agents, especially E. coli gene engineering products；
  8. Voluntary participation, good compliance, cooperate with the experimental observation, and sign a written informed consent。

Exclusion Criteria:

  1. Inert T cell lymphoma (such as mycosis fungoides /Sezary syndrome), ALK positive anaplastic large cell lymphoma；
  2. Patients who received chemotherapy drugs in the past;
  3. Pregnant women,lactating women,or having fertility but not taking contraceptive measures；
  4. Patients with serious uncontroled acute infection;or suppurative and chronic infection and unhealing wound；
  5. Patients with original serious heart disease, including: high-risk cardiac arrhythmias of congestive heart failure,uncontroled instability angina, myocardial infarction and severe heart valve disease and intractable hypertension；
  6. Patients with less control of the nervous, mental illness or mental disorders, poor compliance, and the description of the treatment response；
  7. Patients with primary central nervous system lymphoma or lymphoma involving central nervous system；
  8. Patients with abnormal coagulation function and severe thrombosis;
  9. Patients who participated in other clinical trials；
  10. The researchers considered that patients should not be in this trial。

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GDP+Endostar

Patients in this group will be given conventional chemotherapy medicine:

GDP (gemcitabine+dexamethasone+cis-platinum)chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma and Endostar.
Drug: GDP
GDP is a a combination therapy,repeated every 21 days. GEM(gemcitabine)1000mg/m2,ivgtt,30,d1、8; DXM(dexamethasone),40mg/d,p.o,d1-4; DDP(cis-platinum),75mg/m2,ivgtt,>1h,d1; or DDP25 mg/m2,ivgtt,>1h,d1-3.
Biological: Endostar

Endostar is a continuous intravenous injection pump, continuous intravenous pumped by seven consecutive days,d1- d7, which is 168 hours .Endostar pumping well dose is 30 mg every 24 hours.

Repeated every 21 days.
Active Comparator: GDP

Patients in this group will be given conventional chemotherapy medicine:

GDP (gemcitabine+dexamethasone+cis-platinum) chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma.
Drug: GDP
GDP is a a combination therapy,repeated every 21 days. GEM(gemcitabine)1000mg/m2,ivgtt,30,d1、8; DXM(dexamethasone),40mg/d,p.o,d1-4; DDP(cis-platinum),75mg/m2,ivgtt,>1h,d1; or DDP25 mg/m2,ivgtt,>1h,d1-3.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR(Overall release rate)
Time Frame: Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase
According to the Cheson standard recommended by NCCN (National Comprehensive Cancer Network)guidelines of USA, the evaluation of the clinical effect of the drug on tumor was evaluated by comparing the change of tumor size and duration.
Change from Baseline at the week 6,12, 18 of treatment phase and the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase

Secondary Outcome Measures

Outcome Measure
Time Frame
PFS（progression-free survival）
Time Frame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
DCR(disease control rate)
Time Frame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
OS（overall survival）
Time Frame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Adverse reaction
Time Frame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase
Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase
The quality of life（QOL） Questionnaire
Time Frame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.
Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase, the month 3, 6, 9 and 12, 15, 18, 21, 24, 27, 30 ,33,36 of the followup phase.

Collaborators and Investigators

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

Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Collaborators

Jiangsu Cancer Institute & 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

December 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

July 26, 2015

First Submitted That Met QC Criteria

August 6, 2015

First Posted (Estimate)

August 11, 2015

Study Record Updates

Last Update Posted (Estimate)

August 11, 2015

Last Update Submitted That Met QC Criteria

August 6, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Endostar-PTLC-001

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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