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

Primary Purpose

Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
chemotherapy followed by radiotherapy
radiotherapy followed by chemotherapy
IPGDP regimen chemotherapy
Sponsored by
Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical CollegeRecruiting
  • People's Hospital of GuangxiRecruiting
  • Fourth Hospital of Hebei Medical UniversityRecruiting
  • Shanxi Dayi HospitalRecruiting
  • Shanxi Province Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

chemotherapy followed by radiotherapy

radiotherapy followed by chemotherapy

IPGDP regimen chemotherapy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

progression-free survival

Secondary Outcome Measures

Full Information

First Posted
September 11, 2015
Last Updated
January 1, 2018
Sponsor
Chinese Academy of Medical Sciences
Collaborators
307 Hospital of PLA, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University, The Second Affiliated Hospital of Dalian Medical University, Hebei Medical University Fourth Hospital, Qilu Hospital of Shandong University, Shandong Cancer Hospital and Institute, Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, People's Hospital of Guangxi, Xuzhou Medical University, Shanxi Province Cancer Hospital, Shanxi Dayi Hospital, Zhangzhou Municipal Hospital of Fujian Province
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1. Study Identification

Unique Protocol Identification Number
NCT02560441
Brief Title
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

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2022 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese Academy of Medical Sciences
Collaborators
307 Hospital of PLA, Tianjin Medical University Cancer Institute and Hospital, First Hospital of China Medical University, The Second Affiliated Hospital of Dalian Medical University, Hebei Medical University Fourth Hospital, Qilu Hospital of Shandong University, Shandong Cancer Hospital and Institute, Nanfang Hospital, Southern Medical University, Guangdong Provincial People's Hospital, People's Hospital of Guangxi, Xuzhou Medical University, Shanxi Province Cancer Hospital, Shanxi Dayi Hospital, Zhangzhou Municipal Hospital of Fujian Province

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized

8. Arms, Groups, and Interventions

Arm Title
chemotherapy followed by radiotherapy
Arm Type
Other
Arm Description
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.
Arm Title
radiotherapy followed by chemotherapy
Arm Type
Other
Arm Description
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.
Arm Title
IPGDP regimen chemotherapy
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
chemotherapy followed by radiotherapy
Intervention Type
Other
Intervention Name(s)
radiotherapy followed by chemotherapy
Intervention Type
Drug
Intervention Name(s)
IPGDP regimen chemotherapy
Primary Outcome Measure Information:
Title
progression-free survival
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuankai Shi
Phone
87788293
Email
syuankaipumc@126.com
Facility Information:
Facility Name
Cancer Institute/Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuankai Shi
Facility Name
People's Hospital of Guangxi
City
Nanning
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiaxin Chen
Facility Name
Fourth Hospital of Hebei Medical University
City
Shijiazhuang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yuhuan Gao
Facility Name
Shanxi Dayi Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiaohua Zhang
Facility Name
Shanxi Province Cancer Hospital
City
Taiyuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liping Su

12. IPD Sharing Statement

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

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