A Study of Improving the Efficacy of Treatment in High Risk T Cell Lymphoma Patients

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a prospective , open, multicenter, randomized phase III study. The investigators planed to include 380 untreated high risk T cell lymphoma adults,to random to CHOP and c-ATT regimen groups after signature the informed consents. The patients will receive safety assessment every cycles, and efficacy evaluation every 3 cycles. Every-two-months follow up will be received after finishing the treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Collaborators: Chinese Academy of Medical Sciences; Fudan University; Tianjin Medical University Cancer Institute and Hospital

Criteria

Inclusion Criteria:

• Age ≥18 and ≤70 years old.

• Histological documented high risk T cell lymphoma:extranodal NK/T-cell lymphoma,hepatosplenic T-cell lymphoma, subcutaneous panniculitis-like T-cell lymphoma,angioimmunoblastic T-cell lymphoma,enteropathy-type T-cell lymphoma, peripheral T-cell lymphoma,unspecified.

• Measurable disease and evaluable lesion.

• Never previously treated with radiotherapy, chemotherapy or surgery for malignant disease.

• Normal Haematological,liver and kidney function (Neutrophil count ≥ 1.5 × 109/L ,hemoglobin ≥ 100g/L,platelets ≥ 100 × 109/L)

• ECOG Performance status 0-3,Life expectancy of at least 3 months.

• Without history of another malignancy

• Without any conflict serious systemic disease

• Without any accompany treatment(including steroids drugs)

• Subjects must have signed and informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

• Female subjects must be practicing and effective methods of birth control for at least 6 months throughout and after study; and have a negative serum β-hCG pregnancy test at screening.

Exclusion Criteria:

• Patients with prior clinical study within 3 months.

• Secondary lymphoma induced by chemotherapy or radiotherapy for another malignancy

• Transformed lymphoma

• Mycosis fungicide/Sézary syndrome（MF/SS）

• History of allergic reaction to any ectogenic proteins

• Prior treatment for lymphoma .

• History of another malignancy

• Neutrophil count < 1.0× 109/L ,hemoglobin < 90g/L,platelets < 90 × 109/L,concurrent treatment with systemic antibiotic or antiviral drug for active infection.

• Decompensated heart failure, dilated cardiomyopathy, coronary artery disease with depression of ST-T for electrocardiogram, myocardial infarction within 6 months

• Serious infective or organic disease

• Kidney dysfunction not related to lymphoma(Creatinine clearance≥ 2× institutional upper limit of normal)

• liver dysfunction not related to lymphoma(transaminase≥3× institutional upper limit of normal,and/or bilirubin≥2.0mg/dl)

• clinical syndrome of encephalon functional disorder,serious psychosis

• female subject who is pregnant or breast-feeding