Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type Clinical Trial
Official title:
A Multicenter Phase II Trial to Evaluate the Safety and Efficacy of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
The first Part: recruiting untreated ENKL patients with extensive stage I or limited stage II
disease (only referring to patients with the invasion of Waldeyer's ring and cervical lymph
nodes) . Patients are randomly divided into two arms, IPGDP regimen chemotherapy followed by
radiotherapy or radiotherapy followed by IPGDP regimen chemotherapy. IPGDP regimen for both
arms are 3 cycles. And the chemotherapy is repeated every 3 weeks..
The second part: recruiting extensive stage II ,stage III-IV, relapsed or refractory ENKL
patients. Patients receive 6 cycles of IPGDP regimen chemotherapy. And the chemotherapy is
repeated every 3 weeks.
The first Part: Patients in IPGDP regimen chemotherapy followed by radiotherapy arm receive 3
cycles of IPGDP (ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase 2000U/m2 im on day 1;
gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5; dexamethasone 20mg/m2
iv on days 3-6) chemotherapy. Then patients undergo radiotherapy. If the disease is
considered to progress or as stable during chemotherapy, the patient will directly receive
radiotherapy. Patients in another arm receive radiotherapy followed by IPGDP regimen
chemotherapy. IPGDP regimen for both arms are 3 cycles, which is repeated every 3 weeks.
The second Part: Patients receive 6 cycles of ifosfamide 1.2g/m2 iv on days 3-5; pegaspargase
2000U/m2 im on day 1; gemcitabine 800mg/m2 iv on days 3,8; cisplatin 25 mg/m2 iv on days 3-5;
dexamethasone 20mg/m2 iv on days 3-6. IPGDP regimen is repeated every 3 weeks. If the disease
is considered to progress or as stable after 2 cycles or 4 cycles of chemotherapy, the
patient will withdraw from this study.
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