Acta Medica Okayama volume73 issue5
2019-10 発行

Phase II Trial Using Romidepsin after Gemcitabine, Dexamethasone, and Cisplatin Therapy in Elderly Transplant-Ineligible Patients with Relapsed/Refractory Peripheral T-Cell Lymphoma: Study Protocol

Yamasaki, Satoshi Department of Hematology and Clinical Research Institute, NHO Kyushu Medical Cente
Kada, Akiko Department of Clinical Trials and Research, Clinical Research Center, NHO Nagoya Medical Center
Nagai, Hirokazu Department ofHematology and Oncology Research, NHO Nagoya Medical Center
Yoshida, Isao Department of Hematologic Oncology, NHO Shikoku Cancer Center
Choi, Ilseung Department of Hematology, NHO Kyushu Cancer Center
Saito, Akiko M. Department of Clinical Trials and Research, Clinical Research Center, NHO Nagoya Medical Center
Iwasakia, Hiromi Department of Hematology and Clinical Research Institute, NHO Kyushu Medical Cente
Publication Date
2019-10
Abstract
Romidepsin is an important therapeutic option for patients with peripheral T-cell lymphoma (PTCL). However, the timing of romidepsin administration remains controversial. Romidepsin was launched in Japan as a consolidation therapy agent after conventional salvage chemotherapy with gemcitabine, dexamethasone, and cisplatin (GDP). GDP therapy will be administered every 3 weeks. If complete response, partial response, or stable disease is confirmed after 2-4 GDP cycles, romidepsin will be administered every 4 weeks. The primary endpoint is a 2-year progression-free survival rate. Patients participating in this study and undergoing treatment can expect results similar to or better than those of conventional therapies.
Document Type
Clinical Study Protocol
Keywords
peripheral T-cell lymphoma not otherwise specified
angioimmunoblastic T-cell lymphoma
gemcitabine
cisplatin, romidepsin
Link to PubMed
Thumnail 73_5_469.pdf 1.94 MB