Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Clinical Trial of Apatinib Combined With CHOP Regimen in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Conditions
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Newly Diagnosed Peripheral T-cell Lymphoma

Intervention / Treatment
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* Drug: Apatinib
* Drug: CHOP Regimen


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apatinib combined with CHOP regimen<br>Apatinib: 250mg/d d1-21 po CHOP regimen(Cyclophosphamide,Vincristine,Epirubicin,Prednisone) ： Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Epirubicin,60mg/m2,ivgtt,d1;Prednisone 60mg/m2,po, d1-5 | Drug: Apatinib<br>* 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.<br>* Other names: Apatinib mesylate;Drug: CHOP Regimen<br>* CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)<br>* Other names: CHOP;|
| Experimental: CHOP regimen<br>CHOP regimen(Cyclophosphamide,Vincristine,Epirubicin,Prednisone) ： Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Epirubicin,60mg/m2,ivgtt,d1;Prednisone 60mg/m2,po, d1-5 | Drug: CHOP Regimen<br>* CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)<br>* Other names: CHOP;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression-free survival | up to end of follow-up-phase (approximately 24 months) | 
| RR | Response Rate | every 6 weeks, up to completion of treatment (approximately 18 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | up to the date of death (approximately 5 years) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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peripheral T-cell lymphoma, Apatinib, targeted therapy, RR, PFS