Treatment of Newly Diagnosed Peripheral T-cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhengzhou University
• Treatments: Apatinib; Cyclophosphamide; Doxorubicin; Epirubicin; Prednisolone; Prednisone; Vincristine

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.