Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
About this trial
This is an interventional treatment trial for Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Eligibility Criteria
Inclusion Criteria:
- histologically proven diagnosis of Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type(ENKL)
- untreated ENKL patients of extensive stage I and limited stage II ( only referring to patients with the invasion of Waldeyer's ring and neck lymph node) confirmed by imaging examination; extensive stage II ,stage III-IV, relapsed or refractory ENKL patients confirmed by imaging examination
- age 18-65 years
- at least one measurable lesions
- Eastern Cooperative Oncology Group (ECOG) of 0 to 1
- a life expectancy of at least 12 weeks
- Adequate organ function including the following:
Bone marrow: absolute neutrophil count (ANC) >or equal to 1.5 * 109/L, platelets >or equal to 100 *109/L, hemoglobin > or equal to 9g/dL.
Hepatic: bilirubin < or equal to 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) < or equal to 2.5 x ULN (AST, ALT < or equal to 5 x ULN is acceptable if liver has been involved).
Renal: serum creatinine < or equal to 1.5 x ULN. Coagulation function :activated partial thromboplastin time < or equal to 1.5 x ULN, fibrinogen > or equal to 0.75 times of the lower limit of the normal value, INR < or equal to 1.5 x ULN.
- informed consent signed by patients prior to commencement of the study
- pregnancy test of Women of childbearing must be negative at the beginning of 7 days before treatment; surgical sterilization or taking contraceptive measures during treatment and three months after the end of treatment for males.
Exclusion Criteria:
- severe allergies to the investigational drugs
- patients who had received unauthorized drugs or drugs of other trials within 4 weeks prior to the study
- Severe or unstable systemic disease,serious neurological or psychiatric diseases including seizures or dementia
- organ function including the following: Bone marrow: absolute neutrophil count (ANC) < 1.5 * 109/L, platelets<100 *109/L, hemoglobin < 9g/dL.
Hepatic: bilirubin > 2 x ULN; aspartate transaminase (AST) and alanine transaminase (ALT) >2.5 x ULN (AST, ALT > 5 x ULN is acceptable if liver has been involved).
Renal: serum creatinine > 1.5 x ULN. Abnormal Coagulation function : such as activated partial thromboplastin time prolonged > 1.5 x ULN, fibrinogen < 0.75 times of the lower limit of the normal value, increased INR > 1.5 x ULN any other important clinical or laboratory abnormalities that are not appropriate for research
- Patients who had previously received treatment of this study, or withdrew from the study
- receiving any other anti-tumor therapy at the same time
- pregnancy or lactation
Sites / Locations
- Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
- People's Hospital of GuangxiRecruiting
- Fourth Hospital of Hebei Medical UniversityRecruiting
- Shanxi Dayi HospitalRecruiting
- Shanxi Province Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Other
Other
Other
chemotherapy followed by radiotherapy
radiotherapy followed by chemotherapy
IPGDP regimen chemotherapy
Patients 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 followed by radiotherapy.
Patients receive radiotherapy followed by 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.
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. 6 cycles, every 3 weeks one cycle.