Clinical trial · Interventional
Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
A Randomized Controlled Clinical Trial of Apatinib Combined With CHOP Regimen in the Treatment of Newly Diagnosed Peripheral T-cell Lymphoma
NCT03631862CI-TRIAL-00034378unknownPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Newly Diagnosed Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Apatinib | Drug | — | UNRESOLVED |
| CHOP Regimen | Drug | CHOP Regimen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Apatinib combined with CHOP regimen
- 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
- interventionNames
- Drug: Apatinib
- Drug: CHOP Regimen
- type
- EXPERIMENTAL
- label
- CHOP regimen
- 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
- interventionNames
- Drug: CHOP Regimen
Primary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.