Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
China100 participantsStarted 2018-09-01
Plain-language 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.
Who can participate
Age range14 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 therapyï¼›
* 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 t…
What they're measuring
1
PFS
Timeframe: up to end of follow-up-phase (approximately 24 months)
2
RR
Timeframe: every 6 weeks, up to completion of treatment (approximately 18 weeks)