Back to resultsGPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Primary Purpose
Extranodal NK/T-cell Lymphoma
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Gemcitabine
Pegaspargase
Etoposide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma
Eligibility Criteria
Inclusion Criteria:
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
- refractory or relapsed after initial remission, or stage III-IV de novo patients
- PET/CT or CT/MRI with at least one objectively evaluable lesion.
- General status ECOG score 0-3 points.
- The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
- Sign the informed consent form
Exclusion Criteria:
Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.
Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.
• Other experimental drugs are being used.
Sites / Locations
- Beijing Tongren HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
treatment arm
Arm Description
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
Outcomes
Primary Outcome Measures
overall response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Secondary Outcome Measures
complete response rate
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
1-year progression free survival rate
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
1-year overall survival rate
time from date of enrollment to date death of any reason
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04917250
Brief Title
GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Official Title
Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Anticipated)
Study Completion Date
August 31, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Tongren Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extranodal NK/T-cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Intervention Description
1000mg/㎡，d1,4 ivdrip
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
2500IU/㎡, maximum dose less than 3750IU
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
100mg/㎡，d1-3 ivdrip
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20mg/d d1-4 ivdrip
Primary Outcome Measure Information:
Title
overall response rate
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
24 weeks ±7 days
Secondary Outcome Measure Information:
Title
complete response rate
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
24 weeks ±7 days
Title
1-year progression free survival rate
Description
time from date of enrollment to date of disease progression, death of any reason, whichever comes first
Time Frame
up to 1year after enrollment
Title
1-year overall survival rate
Description
time from date of enrollment to date death of any reason
Time Frame
up to 1year after enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.
refractory or relapsed after initial remission, or stage III-IV de novo patients
PET/CT or CT/MRI with at least one objectively evaluable lesion.
General status ECOG score 0-3 points.
The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.
Sign the informed consent form
Exclusion Criteria:
Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.
Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.
Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.
• Other experimental drugs are being used.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liang Wang, M.D.
Phone
+861058268442
Email
wangliangtrhos@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liang Wang, M.D.
Organizational Affiliation
Beijing Tongren Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Tongren Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liang Wang, M.D.
Phone
+861058268442
Email
wangliangtrhos@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
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