T Cell Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Chidamide Plus CHOEP Combined With Upfront ASCT in Untreated Peripheral T-cell Lymphoma
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.
Chidamide+Cyclophosphamide+Epirubicin+Vindesine+Etoposide+Prednisone Six cycles of therapy
administered every 28 days were planned. Cyclophosphamide 750mg/m2 IV d1; epirubicin 70mg/m2
IV d1; Vindesine 4mg IV d1; etoposide 100mg IV d1-3; prednisone 60mg/m2 PO d1-5.
Chidamide:
Phase I: Patients were treated at the following bortezomib dose levels: 15, 20, and 25 mg
twice per week.
Dose escalation and reduction were on the basis of the continual reassessment method, with
at least two patients per dose level and no dose level skipped. No intrapatient dose
escalation will be allowed. If one patient experienced dose-limiting toxicity (DLT), three
additional patients were added to the dose level. If two of six patients experienced DLT,
the previous dose level was declared the MTD. If only one of six patients experienced DLT,
dose escalation was permitted to continue. DLT refers only to toxic events that occur during
the first cycle of treatment.
At least 9(3+3+3) patients will be enrolled in Phase I study. Phase II: If MTD was not
reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as
experimental dose.
After 3 Cycles, patients who become PD should withdraw the trial and receive other regimens;
patients who become CR and eligible for auto-SCT will undergo auto-SCT; patients who get PR
will receive 3 more cycles C-CHOEP regimen treatment, CR patients in them undergo auto-SCT,
non-CR patients undergo follow-up phase.
All the patients will continue to receive chidamide treatment until progression of the
disease (PD), unacceptable toxicity, or patient/investigator discretion.
During follow-uo phase, surveillance imaging with CT scans can be performed every 6 months
up to the first 2 years, followed by doctor visit every 6 months up to 5 years or the
disease relapses.
from recruiting the first subject until the last recruited subject finished his 2 years
follow-up phase or the disease relapsed
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment