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

Peripheral T-cell Lymphomas Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02520219
• Other study ID #: Endostar-PTLC-001
• Status: Recruiting
• Phase: Phase 2
• First received: July 26, 2015
• Last updated: August 6, 2015
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: August 2015
• Source: Nanjing NingQi Medicine Science and Technology Co., Ltd.
• Contact: Yin Qingfeng, manager
• Phone: 0086-025-85632992
• Email: y_qingfeng[@]163.com
• Is FDA regulated: No
• Health authority: China:Nanjing NingQi pharmaceutical technology co., LTD
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Peripheral T-cell Lymphomas

Intervention

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.

Locations

Country	Name	City	State
China	Jiangsu province tumor hospital	Nanjing City	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Nanjing NingQi Medicine Science and Technology Co., Ltd.	Jiangsu Cancer Institute & Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	No
Secondary	PFS(progression-free survival)		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.	No
Secondary	DCR(disease control rate)		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.	No
Secondary	OS(overall survival)		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.	No
Secondary	Adverse reaction		Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase	Yes
Secondary	The quality of life(QOL) Questionnaire		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.	No