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

Shanghai Jiao Tong University

Status and phase

Unknown

Phase 2

Conditions

Peripheral T Cell Lymphoma

Treatments

Drug: Chidamide

Study type

Interventional

Funder types

Other

Identifiers

NCT02753543

RJ-PTCL-2016-01

Details and patient eligibility

About

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.

Enrollment

33 estimated patients

Sex

All

Ages

16 to 75 years old

Volunteers

No Healthy Volunteers

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