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.
Status | Recruiting |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | September 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
China | Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Beijing | |
China | People's Hospital of Guangxi | Nanning | |
China | Fourth Hospital of Hebei Medical University | Shijiazhuang | |
China | Shanxi Dayi Hospital | Taiyuan | |
China | Shanxi Province Cancer Hospital | Taiyuan |
Lead Sponsor | Collaborator |
---|---|
Chinese Academy of Medical Sciences | 307 Hospital of PLA, First Hospital of China Medical University, Guangdong General Hospital, Hebei Medical University Fourth Hospital, Nanfang Hospital of Southern Medical University, People's Hospital of Guangxi, Qilu Hospital of Shandong University, Shandong Cancer Hospital and Institute, Shanxi Dayi Hospital, Shanxi Province Cancer Hospital, The Second Affiliated Hospital of Dalian Medical University, Tianjin Medical University Cancer Institute and Hospital, Xuzhou Medical University, Zhangzhou Municipal Hospital of Fujian Province |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | progression-free survival | 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
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