Clinical trial · Interventional
MEDA Chemotherapy and Autologous Hematopoietic Stem Cell Transplantation for Stage IV Natural Killer/T-cell Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK-T-Cell Lymphoma, Nasal Type | Extranodal NK-/T-Cell Lymphoma, Nasal Type | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Auto-HSCT | Procedure | — | UNRESOLVED |
| MEDA | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MEDA/Auto-HSCT
- description
- Patients will be initially treated with four cycles MEDA chemotherapy, followed by autologous hematopoietic stem cell transplantation (Auto-HSCT).
- interventionNames
- Drug: MEDA
- Procedure: Auto-HSCT
Primary outcomes (1)
- measure
- Complete response rate
- timeFrame
- Day 28 of the 4th course of MEDA chemotherapy
- description
- The complete response rate will be assessed on day 28 of the 4th course of MEDA chemotherapy.
Secondary outcomes (4)
- measure
- Progression free survival
- timeFrame
- 2-year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
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