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

Primary Purpose

Peripheral T-cell Lymphomas

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

GDP

Endostar

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphomas focused on measuring Peripheral T-cell lymphomas,Endostar

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Newly diagnosed or relapsed PTCL patients by pathology, and / or cytology examination, which are required to receive chemotherapy;
At least 1 single size measurable lesions, CT, MRI, Bultrasound scan or PET-CT scan shows more than 15mm；
Physical condition is good: ECOG score between 0-2 points；
The expected survival time is more than 3 months；
Age 18 years or older,unlimited gender；
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
No serious allergic reaction to biological agents, especially E. coli gene engineering products；
Voluntary participation, good compliance, cooperate with the experimental observation, and sign a written informed consent。

Exclusion Criteria:

Inert T cell lymphoma (such as mycosis fungoides /Sezary syndrome), ALK positive anaplastic large cell lymphoma；
Patients who received chemotherapy drugs in the past;
Pregnant women,lactating women,or having fertility but not taking contraceptive measures；
Patients with serious uncontroled acute infection;or suppurative and chronic infection and unhealing wound；
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；
Patients with less control of the nervous, mental illness or mental disorders, poor compliance, and the description of the treatment response；
Patients with primary central nervous system lymphoma or lymphoma involving central nervous system；
Patients with abnormal coagulation function and severe thrombosis;
Patients who participated in other clinical trials；
The researchers considered that patients should not be in this trial。

Sites / Locations

Jiangsu province tumor hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

GDP+Endostar

GDP

Arm Description

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.

Patients in this group will be given conventional chemotherapy medicine: GDP (gemcitabine+dexamethasone+cis-platinum) chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma.

Outcomes

Primary Outcome Measures

ORR(Overall release rate)

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.

Secondary Outcome Measures

PFS（progression-free survival）

DCR(disease control rate)

OS（overall survival）

Adverse reaction

The quality of life（QOL） Questionnaire

Full Information

NCT ID

NCT02520219

First Posted

July 26, 2015

Last Updated

August 6, 2015

Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Collaborators

Jiangsu Cancer Institute & Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02520219

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Unknown status

Study Start Date

December 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nanjing NingQi Medicine Science and Technology Co., Ltd.

Collaborators

Jiangsu Cancer Institute & Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphomas

Keywords

Peripheral T-cell lymphomas,Endostar

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

GDP+Endostar

Arm Type

Experimental

Arm Description

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.

Arm Title

GDP

Arm Type

Active Comparator

Arm Description

Patients in this group will be given conventional chemotherapy medicine: GDP (gemcitabine+dexamethasone+cis-platinum) chemotherapy by treatment guidelines for Peripheral T-cell Lymphoma.

Intervention Type

Drug

Intervention Name(s)

GDP

Intervention Description

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.

Intervention Type

Biological

Intervention Name(s)

Endostar

Intervention Description

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.

Primary Outcome Measure Information:

Title

ORR(Overall release rate)

Description

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

Secondary Outcome Measure Information:

Title

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.

Title

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.

Title

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.

Title

Adverse reaction

Time Frame

Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Newly diagnosed or relapsed PTCL patients by pathology, and / or cytology examination, which are required to receive chemotherapy; At least 1 single size measurable lesions, CT, MRI, Bultrasound scan or PET-CT scan shows more than 15mm； Physical condition is good: ECOG score between 0-2 points； The expected survival time is more than 3 months； Age 18 years or older,unlimited gender； 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 No serious allergic reaction to biological agents, especially E. coli gene engineering products； Voluntary participation, good compliance, cooperate with the experimental observation, and sign a written informed consent。 Exclusion Criteria: Inert T cell lymphoma (such as mycosis fungoides /Sezary syndrome), ALK positive anaplastic large cell lymphoma； Patients who received chemotherapy drugs in the past; Pregnant women,lactating women,or having fertility but not taking contraceptive measures； Patients with serious uncontroled acute infection;or suppurative and chronic infection and unhealing wound； 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； Patients with less control of the nervous, mental illness or mental disorders, poor compliance, and the description of the treatment response； Patients with primary central nervous system lymphoma or lymphoma involving central nervous system； Patients with abnormal coagulation function and severe thrombosis; Patients who participated in other clinical trials； The researchers considered that patients should not be in this trial。

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yin Qingfeng, manager

Phone

0086-025-85632992

y_qingfeng@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Zhou Xiaolei, sponsor

Phone

0086-02585566666

zhouxiaolei@simcere.com

Facility Information:

Facility Name

Jiangsu province tumor hospital

City

Nanjing City

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qingfeng Yin, Clinical Manager

Phone

0086013912903257

y_qingfeng@163.com

First Name & Middle Initial & Last Name & Degree

Xiaolei Zhou, Manager

Phone

0086013776639377

zhouxiaolei@simcere.com

12. IPD Sharing Statement

Learn more about this trial

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

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