Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

NCT03631862 | Unknown Phase 4

• 1 other identifier: hnslblzlzx2018-5
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

peripheral T-cell lymphoma; Apatinib; targeted therapy; RR; PFS

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• OS

  up to the date of death (approximately 5 years)

Study Arms (2)

Apatinib combined with CHOP regimen

EXPERIMENTAL

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; Drug: CHOP Regimen

CHOP regimen

EXPERIMENTAL

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

Interventions

Apatinib DRUG

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.

Also known as: Apatinib mesylate

Apatinib combined with CHOP regimen

CHOP Regimen DRUG

CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)

Also known as: CHOP

Apatinib combined with CHOP regimen; CHOP regimen

Eligibility Criteria

• Age: 14 Years - 70 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhengzhou University: lead

Study Sites (1)

Oncology Department of The First Affilliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

apatinib; VAP-cyclo protocol

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Mingzhi Zhang, Pro,Dr

  China, Henan Oncology Department of The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingzhi Zhang, Pro,Dr

CONTACT

13838565629; Mingzhi_zhang@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: the director of oncology department of the first affiliated hospital

Study Record Dates

• First Submitted: August 12, 2018
• First Posted: August 15, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 15, 2018

Record last verified: 2018-08

Locations

CN (1)