The purpose of this study is to evaluate the efficacy and safety of methotrexate, etoposide, pegaspargase and dexamethasone (MEDA) chemotherapy and autologous hematopoietic stem cell transplantation (Auto-HSCT) in patients with stage IV extranodal natural killer/T-cell lymphoma, nasal type.
Extranodal natural killer/T-cell lymphoma (ENKTCL), nasal type, is a rare subtype of non-Hodgkin lymphoma (NHL) with relatively high incidence in China. L-asparaginase based chemotherapy improved overall response and prolonged the long-term survival for patients with stage IV. But the optimal treatment schedule has not been established. This study is designed with four cycles MEDA chemotherapy, followed by Auto-HSCT for stage IV patients with newly onset, relapsed or refractory diseases. The efficacy and safety of this protocol in the treatment of will be measured.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Methotrexate, 3.0g/m2/d iv, day 1 Etoposide, 100mg/m2 iv, day 2 to day 4 Dexamethasone, 40mg/d iv, day 1 to day 4 Pegaspargase, 2500IU/m2/d im, day 4 The MEDA chemotherapy will be repeated every 3 weeks.
Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
Shanghai Ninth People's Hospital
Shanghai, Shanghai Municipality, China
Shanghai Eye Ear Nose and Throat Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Xinhua Hospital
Shanghai, Shanghai Municipality, China
Complete response rate
The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Time frame: Day 28 of the 4th course of MEDA chemotherapy
Progression free survival
Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason.
Time frame: 2-year
Overall response rate
The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Time frame: Day 28 of the 4th course of MEDA chemotherapy
Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0.
Time frame: Day 1 of each course of chemotherapy and then every 3 months for 2 years
Overall survival
Overall survival is defiend as the time from entry onto the treatment until death of any reason
Time frame: 2-year
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Shanghai Dong Fang hospital
Shanghai, Shanghai Municipality, China
Shanghai Tong Ren Hospital
Shanghai, Shanghai Municipality, China
Xin Jiang People's Hospital
Ürümqi, Xinjiang, China