Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

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

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.

Study Overview

• Status: Unknown
• Conditions: Newly Diagnosed Peripheral T-cell Lymphoma
• Intervention / Treatment: Drug: Apatinib; Drug: CHOP Regimen

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 Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Henan
    • Zhengzhou, Henan, China, 450052
      • Recruiting
      • Oncology Department of The First Affilliated Hospital of Zhengzhou University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apatinib combined with 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	Drug: Apatinib; 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.; Other Names: Apatinib mesylate; Drug: CHOP Regimen; CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone); Other Names: CHOP
Experimental: 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	Drug: CHOP Regimen; CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone); Other Names: CHOP

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Zhengzhou University
• Investigators: Principal Investigator: Mingzhi Zhang, Pro,Dr, China, Henan Oncology Department of The First Affiliated Hospital of Zhengzhou University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: August 12, 2018
• First Submitted That Met QC Criteria: August 12, 2018
• First Posted (Actual): August 15, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2018
• Last Update Submitted That Met QC Criteria: August 12, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Apatinib; targeted therapy; PFS; RR; peripheral T-cell lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Protein Kinase Inhibitors; Apatinib
• Other Study ID Numbers: hnslblzlzx2018-5

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No