Chidamide Plus Chemotherapy in the Treatment of Peripheral T-cell Lymphoma

• Status: Unknown status
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single arm, prospective trial to evaluate the efficacy and safety of Chidamide in combination with previous chemotherapy in peripheral T cell lymphoma patients who did not achieve complete response after 3 cycles of chemotherapy in interim evaluation.

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

Details

• Lead Sponsor: Ruijin Hospital

Criteria

Inclusion Criteria:

• Pathologically verified peripheral T-cell lymphoma, partial response or stable disease after 3 cycles of CEOP (cyclophosphamide, epirubicin or doxorubicin, vincristine and prednisone) or CEOP(cyclophosphamide,vincristin,epirubicin and prednisone)/IVE (ifosfamide, epirubicin, etoposide)/GDP(Gemcitabine, Cis-platinum, Dexamethasone)

• Age ≧16 years, ≦75 years

• ECOG (Eastern Cooperative Oncology Group) =0,1,2

• No previous history of malignancy

• Radiologically measurable disease

• Life expectancy>6 months

• Informed consented

Exclusion Criteria:

• Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy

• Lab at enrollment(unless caused by lymphoma)

• Neutrophile<1.5*10^9/L

• Platelet<75*10^9/L

• Hemoglobulin<90g/L

• ALT(alanine aminotransferase) or AST (aspartate aminotransferase ) >2*ULN,AKP(alkaline phosphatase) or bilirubin >1.5*ULN (upper limit of normal )

• Creatinine>1.5*ULN

• Other uncontrollable medical condition that may that may interfere the participation of the study

• Not able to comply to the protocol for mental or other unknown reasons

• Pregnant or lactation

• HIV infection