MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MEDA/Auto-HSCT Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT). |
Drug: MEDA
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.
Other Names:
Procedure: Auto-HSCT
Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Shanghai Ninth People's Hospital | Shanghai | Shanghai | China | 200011 |
| 2 | Shanghai Eye Ear Nose and Throat Hospital, Fudan University | Shanghai | Shanghai | China | 200031 |
| 3 | Zhongshan Hospital, Fudan University | Shanghai | Shanghai | China | 200032 |
| 4 | Xinhua Hospital | Shanghai | Shanghai | China | 200092 |
| 5 | Shanghai Dong Fang hospital | Shanghai | Shanghai | China | 200120 |
| 6 | Shanghai Tong Ren Hospital | Shanghai | Shanghai | China | 200336 |
| 7 | Xin Jiang People's Hospital | Urumqi | Xinjiang | China | 830001 |
Sponsors and Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Investigators
- Study Chair: Rong Tao, MD, Xinhua hospital, Shanghai Jiao Tong University of Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XHLSG-NK-1602