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Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Primary Purpose

Newly Diagnosed Peripheral T-cell Lymphoma

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

Apatinib

CHOP Regimen

About this trial

This is an interventional treatment trial for Newly Diagnosed Peripheral T-cell Lymphoma focused on measuring peripheral T-cell lymphoma, Apatinib, targeted therapy, RR, PFS

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Oncology Department of The First Affilliated Hospital of Zhengzhou UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Apatinib combined with CHOP regimen

CHOP regimen

Arm Description

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(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

Outcomes

Primary Outcome Measures

PFS

Progression-free survival

Response Rate

Secondary Outcome Measures

Overall Survival

Full Information

NCT ID

NCT03631862

First Posted

August 12, 2018

Last Updated

August 12, 2018

Sponsor

Zhengzhou University

1. Study Identification

Unique Protocol Identification Number

NCT03631862

Brief Title

Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 1, 2018 (Anticipated)

Primary Completion Date

December 31, 2019 (Anticipated)

Study Completion Date

December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Zhengzhou University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Newly Diagnosed Peripheral T-cell Lymphoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apatinib combined with CHOP regimen

Arm Type

Experimental

Arm Description

Arm Title

CHOP regimen

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Apatinib

Other Intervention Name(s)

Apatinib mesylate

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

CHOP Regimen

Other Intervention Name(s)

CHOP

Intervention Description

CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)

Primary Outcome Measure Information:

Title

PFS

Description

Progression-free survival

Time Frame

up to end of follow-up-phase (approximately 24 months)

Title

Description

Response Rate

Time Frame

every 6 weeks, up to completion of treatment (approximately 18 weeks)

Secondary Outcome Measure Information:

Title

Description

Overall Survival

Time Frame

up to the date of death (approximately 5 years)

10. Eligibility

Sex

All

Gender Based

Yes

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

Mingzhi_zhang@126.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Oncology Department of The First Affilliated Hospital of Zhengzhou University

City

Zhengzhou

State/Province

Henan

ZIP/Postal Code

450052

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mingzhi Zhang, Pro,Dr

Phone

13838565629

mingzhi_zhang@126.com

12. IPD Sharing Statement

Learn more about this trial

Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

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