Endostar Aggressive Treatment of Peripheral T-cell Lymphoma (PTCL) Phase II Clinical Study
NCT ID: NCT02520219
Last Updated: 2015-08-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
60 participants
INTERVENTIONAL
2014-12-31
2015-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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。
18 Years
75 Years
ALL
No
Sponsors
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Jiangsu Cancer Institute & Hospital
OTHER
Nanjing NingQi Medicine Science and Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Jiangsu province tumor hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Endostar-PTLC-001
Identifier Type: -
Identifier Source: org_study_id
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