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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MEDA/Auto-HSCT | Experimental | Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MEDA | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate | The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy. | Day 28 of the 4th course of MEDA chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival | Progression free survival is the time from entry onto the treatment until lymphoma progression or death of any reason. | 2-year |
| Overall response rate | The overall response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy. |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Rong Tao, MD | Xinhua hospital, Shanghai Jiao Tong University of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Ninth People's Hospital | Shanghai | Shanghai Municipality | 200011 | China | ||
| Shanghai Eye Ear Nose and Throat Hospital, Fudan University |
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|
| Auto-HSCT | Procedure | Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen. |
|
| 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. | 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 | 2-year |
| Shanghai |
| Shanghai Municipality |
| 200031 |
| China |
| Zhongshan Hospital, Fudan University | Shanghai | Shanghai Municipality | 200032 | China |
| Xinhua Hospital | Shanghai | Shanghai Municipality | 200092 | China |
| Shanghai Dong Fang hospital | Shanghai | Shanghai Municipality | 200120 | China |
| Shanghai Tong Ren Hospital | Shanghai | Shanghai Municipality | 200336 | China |
| Xin Jiang People's Hospital | Ürümqi | Xinjiang | 830001 | China |
| ID | Term |
|---|---|
| D054391 | Lymphoma, Extranodal NK-T-Cell |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008727 | Methotrexate |
| D005047 | Etoposide |
| ID | Term |
|---|---|
| D000630 | Aminopterin |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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