Extranodal NK-T-Cell Lymphoma, Nasal Type
Conditions
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.
Interventions
DRUGMEDA
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.
PROCEDUREAuto-HSCT
Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
Sponsors
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete response rate | Day 28 of the 4th course of MEDA chemotherapy | The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression free survival | 2-year | Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason. |
| Overall response rate | Day 28 of the 4th course of MEDA chemotherapy | The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy. |
| Treatment-Related Adverse Events as Assessed by CTCAE v4.0 | Day 1 of each course of chemotherapy and then every 3 months for 2 years | Treatment-Related Adverse Events will be assessed and graded by NCI CTCAE v4.0. |
| Overall survival | 2-year | Overall survival is defiend as the time from entry onto the treatment until death of any reason |
Countries
China
Outcome results
None listed