Trial of IPGDP Regimen Chemotherapy in Patients With Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

• Status: Recruiting
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chinese Academy of Medical Sciences
• Collaborators: 307 Hospital of PLA; First Hospital of China Medical University; Guangdong General Hospital; Guangdong Provincial People's Hospital; Hebei Medical University Fourth Hospital; Nanfang Hospital of Southern Medical University; People's Hospital of Guangxi; Qilu Hospital; 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

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