Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Newly Diagnosed Peripheral T-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03631862
• Other study ID #: hnslblzlzx2018-5
• Status: Recruiting
• Phase: Phase 4
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2018
• Source: Zhengzhou University
• Contact: Mingzhi Zhang, Pro,Dr
• Phone: 13838565629
• Email: Mingzhi_zhang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, T-Cell
• Lymphoma, T-Cell, Peripheral
• Newly Diagnosed Peripheral T-cell Lymphoma

Intervention

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.
• CHOP Regimen
CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)

Locations

Country	Name	City	State
China	Oncology Department of The First Affilliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	Progression-free survival	up to end of follow-up-phase (approximately 24 months)
Primary	RR	Response Rate	every 6 weeks, up to completion of treatment (approximately 18 weeks)
Secondary	OS	Overall Survival	up to the date of death (approximately 5 years)