A Phase 2 interventional study of Chidamide and prednisone in Peripheral T-cell Lymphoma, sponsored by Sun Yat-sen University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-10-26.
Sponsored by Sun Yat-sen University · Phase 2, Interventional, and Treatment
To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.
Prednisone, cyclophosphamide, etoposide, and methotrexate regimens are derived from a "metronidazole, etoposide, procarbazine and cyclophosphamide (PEPC) regimen" regimen that differs from the traditional "maximal Tolerance "chemotherapy, and the use of low-dose chemotherapy, frequent drug therapy, the purpose is to anti-angiogenesis and reduce drug resistance. At present, the program in our treatment of relapsed or refractory PTCL patients effective, safe and controllable, but also look forward to other joint treatment, so as to achieve better curative effect. To provide new treatment options for such patients.
Exclusion Criteria:
Chidamide + prednisone+cyclophosphamide+etoposide+methotrexate
Drug: Chidamide · Drug: prednisone · Drug: Cyclophosphamide · Drug: etoposide · Drug: Methotrexate
Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
oral, 20mg / day,after breakfast
oral, 50mg / day,after lunch
oral, 50mg / day,after dinner
oral, 10mg / times, once a week,after breakfast
Objective response rate
the total proportion of patients with complete response(CR or CRu)and partial response(PR)
Time frame: every 8 weeks until 2 years after last patient's enrollment
Duration of response
Duration of complete response(CR or CRu)and partial response(PR)
Time frame: every 8 weeks until 2 years after last patient's enrollment
Progress Free Survival(PFS)
Time from treatment until disease progression or death
Time frame: 2 years
Overall Survival
Time from treatment until death from any cause
Time frame: 2 years
Plan to share: Undecided
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Sun Yat-sen University