NCT03321890

Chidamide Combined With PECM in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

A Multicenter, Single-arm, Open II Phase Clinical Trial Evaluating the Efficacy of Chidamide Combined With Prednisone, Cyclophosphamide, Etoposide, and Methotrexate (PECM) in Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 102 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To observe the efficacy and safety of Chidamide combined with prednisone, cyclophosphamide, etoposide and methotrexate in relapsed or refractory PTCL.

Detailed description

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.

Conditions

• Peripheral T-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
DRUG	prednisone	oral, 20mg / day,after breakfast
DRUG	Cyclophosphamide	oral, 50mg / day,after lunch
DRUG	etoposide	oral, 50mg / day,after dinner
DRUG	Methotrexate	oral, 10mg / times, once a week,after breakfast

Timeline

• Start date: 2017-03-07
• Primary completion: 2020-12-01
• Completion: 2020-12-31
• First posted: 2017-10-26
• Last updated: 2017-10-26

Locations

1 site across 1 country: China