Newly Diagnosed Peripheral T-cell Lymphoma
Conditions
Keywords
peripheral T-cell lymphoma, Apatinib, targeted therapy, RR, PFS
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.
Detailed description
Patients with peripheral T-cell lymphoma usually have a bad prognosis. These patients cannot be treated successfully with the conventional CHOP regimen. Apatinib is a small-molecule multitargeted tyrosine kinase inhibitor. The investigators have been proceeding this trial to evaluate the efficacy and safety of the Apatinib Combined With CHOP Regimen(cyclophosphamide, vincristine, epirubicin, prednisone in the treatment of newly diagnosed peripheral T-cell lymphoma.
Interventions
DRUGApatinib
Apatinib is an orally administrated small molecule receptor tyrosine kinase inhibitor selectively targeting VEGFR-2, showing anti-tumor activity across a broad range of advanced cancers.
DRUGCHOP Regimen
CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)
Sponsors
Zhengzhou University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age range 14-70 years old; ECOG performance status 0-2. * Estimated survival time \> 6 months. * Histological confirmed Peripherial T-cell lymphoma. * Have taken no treatment. * None of chemotherapy contraindication: hemoglobin ≥ 90 g/dl, neutrophil ≥ 1.5×109/L, platelet ≥ 100×109/L, ALT and AST ≤ 2×ULN, serum bilirubin ≤ 1.5×ULN, serum creatine ≤ 1.5×upper limitation of normal (ULN), Serum Albumin ≥ 30g/L, serum plasminogen is normal. * At least one measurable lesion. * None of other serious diseases, cardiopulmonary function is normal. * Pregnancy test of women at reproductive age must be negative. * Patients could be followed up. * None of other relative treatments including the traditional Chinese medicine, immunotherapy, biotherapy except anti-bone metastasis therapy and other symptomatic treatments. * Volunteers who signed informed consent.
Exclusion criteria
* Patients with contraindications (active bleeding, ulcers, intestinal perforation, intestinal obstruction, 30 days after major surgery, hypertension uncontrollable drugs, grade III-IV cardiac insufficiency, severe liver and kidney dysfunction); * Abnormal coagulation (INR \> 1.5 or prothrombin time (PT) \> ULN + 4 seconds or APTT \> 1.5 ULN), with bleeding tendency or undergoing thrombolysis or anticoagulant therapy； * Urine routine indicates urinary protein ≥ ++, or confirmed 24-hour urine protein ≥ 1.0 g; * Disagreement on blood sample collection. * Patients allergic of any of drug in this regimen or with metabolic disorder. * Pregnant or lactating women. * Serious medical illness likely to interfere with participation. * Serious infection. * Primitive or secondary tumors of central nervous system. * Chemotherapy or radiotherapy contraindication. * The evidence of CNS metastasis. * History of peripheral nervous disorder or dysphrenia. * Patients participating in other clinical trials. * Patients taking other antitumor drugs. * Patients estimated to be unsuitable by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to end of follow-up-phase (approximately 24 months) | Progression-free survival |
| RR | every 6 weeks, up to completion of treatment (approximately 18 weeks) | Response Rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OS | up to the date of death (approximately 5 years) | Overall Survival |
Countries
China
Contacts
Primary ContactMingzhi Zhang, Pro,Dr
Outcome results
None listed