Clinical trial NCT03631862: 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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Newly Diagnosed Peripheral T-cell Lymphoma
Keywords: peripheral T-cell lymphoma
Apatinib
targeted therapy
RR
PFS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PFS
timeFrame: up to end of follow-up-phase (approximately 24 months)
measure: RR
timeFrame: every 6 weeks, up to completion of treatment (approximately 18 weeks)
Secondary outcomes:
measure: OS
timeFrame: up to the date of death (approximately 5 years)
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affilliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: China, Henan Oncology Department of The First Affiliated Hospital of Zhengzhou University
name: Mingzhi Zhang, Pro,Dr
role: PRINCIPAL_INVESTIGATOR
References: