Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Phase 4

• Conditions: Newly Diagnosed Peripheral T-cell Lymphoma
• Interventions: Drug: Apatinib; Drug: CHOP Regimen

• Registration Number: NCT03631862
• Lead Sponsor: Zhengzhou University

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.

Study Timeline

• Status Verified: 2018-08
• Study First Submitted: 2018-08-12
• Study First Submitted QC: 2018-08-12
• Last Update Submitted: 2018-08-12
• Study First Posted: 2018-08-15
• Last Update Posted: 2018-08-15
• Study Start: 2018-09-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Apatinib combined with CHOP regimen	CHOP Regimen	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
CHOP regimen	CHOP Regimen	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
Apatinib combined with CHOP regimen	Apatinib	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
OS	up to the date of death (approximately 5 years)	Overall Survival

Trial Locations

Locations (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China