Clinical trial NCT02520219: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Peripheral T-cell Lymphomas
Keywords: Peripheral T-cell lymphomas,Endostar
Lead sponsor: Nanjing NingQi Medicine Science and Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Jiangsu Cancer Institute & Hospital
First posted: 2015-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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。

Primary outcomes:
measure: ORR(Overall release rate)
timeFrame: 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 outcomes:
measure: PFS（progression-free survival）
timeFrame: 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.
measure: DCR(disease control rate)
timeFrame: 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.
measure: OS（overall survival）
timeFrame: 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.
measure: Adverse reaction
timeFrame: Change from Baseline at the week 3, 6, 9, 12, 15,18 of the treatment phase
measure: The quality of life（QOL） Questionnaire
timeFrame: 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.
Other outcomes:
Locations:
city: Nanjing City
country: China
facility: Jiangsu province tumor hospital
state: Jiangsu
Study officials:
References: