Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine determine the maximum tolerated dose (MTD) and safety of the combination of Chidamide combined with CHOEP(cyclophosphamide， epirubicin,vindesine, etoposide and prednisone) regimen as first line treatment in newly-diagnosed T-NHL.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Collaborators: Beijing Cancer Hospital; Chinese PLA General Hospital; Peking University First Hospital; Peking University Third Hospital; Tianjin Medical University Cancer Institute and Hospital
• Treatments: Cyclophosphamide; Epirubicin; Etoposide; Etoposide phosphate; Prednisone; Vindesine

Criteria

Inclusion Criteria:

• Newly-diagnosed T cell non-Hodgkin's lymphoma patients. Diagnosis of T cell NHL was performed by morphologic analysis of tissue pathological specimens along with Immunohistochemistry (IHC)

• ECOG≤2

• At least one or more unidimensionally measurable lesions (≥1 cm by CT scan or skin lesions or a measurable lesion by physical examination)

• Sign the Informed consent

• Women of childbearing potential must understand that the study medication could have a potential teratogenic risk. They should undergo complete contraception during the study period.

• Male subjects must agree to use condoms throughout study drug therapy.

Exclusion Criteria:

• T lymphoblastic leukemia/lymphoma

• Bone marrow involvement and lymphoma cell ≥ 25%

• Aplastic large T cell lymphoma - ALK positive

• NK/T-cell lymphoma

• Mycosis Fungoides/Sezary Syndrome

• Pre-existing uncontrolled active infection

• Clinical evidence of grade 3 or 4 heart failure as defined by the New York Heart Association criteria

• Grade 3 or 4 peripheral neuropathy

• Pregnancy or active lactation

• Co-existing tumors

• Impaired renal/ hepatic function (serum creatinine >1.5 mg/dl or creatinine clearance <60 ml/min or serum transaminases/ bilirubin ≥3 upper limits of normal）

• History of mental illness