Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
NCT ID: NCT02560441
Last Updated: 2018-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
INTERVENTIONAL
2015-09-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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chemotherapy followed by radiotherapy
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.
chemotherapy followed by radiotherapy
radiotherapy followed by chemotherapy
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.
radiotherapy followed by chemotherapy
IPGDP regimen 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.
IPGDP regimen chemotherapy
Interventions
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chemotherapy followed by radiotherapy
radiotherapy followed by chemotherapy
IPGDP regimen chemotherapy
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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307 Hospital of PLA
OTHER
Tianjin Medical University Cancer Institute and Hospital
OTHER
First Hospital of China Medical University
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Hebei Medical University Fourth Hospital
OTHER
Qilu Hospital of Shandong University
OTHER
Shandong Cancer Hospital and Institute
OTHER
Nanfang Hospital, Southern Medical University
OTHER
Guangdong Provincial People's Hospital
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Xuzhou Medical University
OTHER
Shanxi Province Cancer Hospital
OTHER
Shanxi Dayi Hospital
OTHER
Zhangzhou Municipal Hospital of Fujian Province
OTHER
Chinese Academy of Medical Sciences
OTHER
Responsible Party
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Shi Yuankai
vice president
Locations
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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, , China
Countries
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Central Contacts
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Facility Contacts
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Yuankai Shi
Role: primary
Jiaxin Chen
Role: primary
Yuhuan Gao
Role: primary
Qiaohua Zhang
Role: primary
Liping Su
Role: primary
Other Identifiers
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CH-LYM-005
Identifier Type: -
Identifier Source: org_study_id
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