Clinical trial NCT02560441: Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: 307 Hospital of PLA
name: Tianjin Medical University Cancer Institute and Hospital
name: First Hospital of China Medical University
name: The Second Affiliated Hospital of Dalian Medical University
name: Hebei Medical University Fourth Hospital
name: Qilu Hospital of Shandong University
name: Shandong Cancer Hospital and Institute
name: Nanfang Hospital, Southern Medical University
name: Guangdong Provincial People's Hospital
name: People's Hospital of Guangxi Zhuang Autonomous Region
name: Xuzhou Medical University
name: Shanxi Province Cancer Hospital
name: Shanxi Dayi Hospital
name: Zhangzhou Municipal Hospital of Fujian Province
First posted: 2015-09-25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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

Primary outcomes:
measure: progression-free survival
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
city: Nanning
country: China
facility: People's Hospital of Guangxi
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
city: Taiyuan
country: China
facility: Shanxi Dayi Hospital
city: Taiyuan
country: China
facility: Shanxi Province Cancer Hospital
Study officials:
References: