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

NCT02560441 | Unknown Phase 2

• 1 other identifier: CH-LYM-005
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 5

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.

Conditions

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  5 years

Study Arms (3)

chemotherapy followed by radiotherapy

OTHER

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.

Other: chemotherapy followed by radiotherapy

radiotherapy followed by chemotherapy

OTHER

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.

Other: radiotherapy followed by chemotherapy

IPGDP regimen chemotherapy

OTHER

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.

Drug: IPGDP regimen chemotherapy

Interventions

chemotherapy followed by radiotherapy OTHER

chemotherapy followed by radiotherapy

radiotherapy followed by chemotherapy OTHER

radiotherapy followed by chemotherapy

IPGDP regimen chemotherapy DRUG

IPGDP regimen chemotherapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• 307 Hospital of PLA: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• First Hospital of China Medical University: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator
• Hebei Medical University Fourth Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Shandong Cancer Hospital and Institute: collaborator
• Nanfang Hospital, Southern Medical University: collaborator
• Guangdong Provincial People's Hospital: collaborator
• People's Hospital of Guangxi Zhuang Autonomous Region: collaborator
• Xuzhou Medical University: collaborator
• Shanxi Province Cancer Hospital: collaborator
• Shanxi Dayi Hospital: collaborator
• Zhangzhou Municipal Hospital of Fujian Province: collaborator

Study Sites (5)

Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College

Beijing, China

RECRUITING

People's Hospital of Guangxi

Nanning, China

RECRUITING

Fourth Hospital of Hebei Medical University

Shijiazhuang, China

RECRUITING

Shanxi Dayi Hospital

Taiyuan, China

RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yuankai Shi

CONTACT

87788293; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: vice president

Study Record Dates

• First Submitted: September 11, 2015
• First Posted: September 25, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2022
• Last Updated: January 3, 2018

Record last verified: 2018-01

Locations

CN (5)