Clinical trial NCT02764281: MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
Official title: The Efficacy and Safety of Methotrexate, Etoposide, Dexamethasone and Pegaspargase Chemotherapy (MEDA) With Autologous HSCT in the Treatment of Stage IV Natural Killer/T-Cell Lymphoma: A Multicenter, Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Extranodal NK-T-Cell Lymphoma, Nasal Type
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2016-05-06
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Pathological diagnosis of extranodal natural killer/T-cell lymphoma, nasal type based on WHO 2008 classification of tumors of haematopoietic and lymphoid tissue.

Eastern Cooperative Oncology Group (ECOG ) performance status 0\~3.

Stage IV disease with at least one measurable lesion.

Preserved organ functions for: Platelet\>50×10\*9/L, hemoglobin\>80g/L, total bilirubin (TBIL)\<3×ULN, alanine transaminase (ALT)\<5×ULN, serum creatinine (Cr)\<1.5×ULN, fibrinogen≥0.5g/L, LVEF≥50%.

Signed Informed consented.

Exclusion Criteria:

Relapsed or progressive disease to prior L-asparaginase-based chemotherapy.

Concurrent cancers need surgery or chemotherapy within 6 months.

History of chemotherapy or radiotherapy for other solid cancers within 3 years.

Recent history of radiotherapy of upper-aero-digestive tract within last 3 months.

Significant complications: LVEF≤50%, coagulopathy, autoimmune disease, severe infection, or liver cirrhosis, severe hemophagocytic lymphohistiocytosis.

Mental disorders.

Pregnant or lactation.

HIV, hepatitis virus C (HCV), or active hepatitis virus B (HBV) infection with HBV DNA≥10\*5 copies/ml.

History of pancreatitis.

Known history for grade 3/4 allergy to the drugs in chemotherapy regimen.

Enrolled in other trial treatment.

Primary outcomes:
measure: Complete response rate
timeFrame: Day 28 of the 4th course of MEDA chemotherapy
Secondary outcomes:
measure: Progression free survival
timeFrame: 2-year
measure: Overall response rate
timeFrame: Day 28 of the 4th course of MEDA chemotherapy
measure: Treatment-Related Adverse Events as Assessed by CTCAE v4.0
timeFrame: Day 1 of each course of chemotherapy and then every 3 months for 2 years
measure: Overall survival
timeFrame: 2-year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Eye Ear Nose and Throat Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Xinhua Hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Dong Fang hospital
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Tong Ren Hospital
state: Shanghai
city: Urumqi
country: China
facility: Xin Jiang People's Hospital
state: Xinjiang
Study officials:
affiliation: Xinhua hospital, Shanghai Jiao Tong University of Medicine
name: Rong Tao, MD
role: STUDY_CHAIR
References: