Back to resultsGPED Regimen for Relapsed/Refractory or Advanced ENKTCL
Primary Purpose
Extranodal NK/T-cell Lymphoma, Nasal Type
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
gemcitabin
Pegaspargase
Etoposide
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Extranodal NK/T-cell Lymphoma, Nasal Type focused on measuring extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome
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.
- 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
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
Outcomes
Primary Outcome Measures
2-year progression free survival (PFS) rate
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
Secondary Outcome Measures
Overall response rate (ORR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Complete response rate (CRR)
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
2-year overall survial (OS) rate
OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04405375
Brief Title
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
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
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 21, 2020 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (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
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients (ENKTCL).
Detailed Description
Pegaspargase is the cornor stone for the treatment of ENKTCL, and gemcitabine has been shown to be active in ENKTCL. For several patients with relapsed/refractory or advance ENKTCL, hemophagocytic sysdrome (HPS) occurs, and the prognosis is very poor. Studies have found that etoposide and dexamethasone may be effective in controlling HPS. Thus, this study aims to evaluate the role of gemcitabine, pegaspargase, etoposide, and dexamethasone (GPED) in the treatment of relapsed/refractory or advance ENKTCL, wishing to improve the prognosis for these 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, Nasal Type
Keywords
extranodal NK/T-cell lymphoma, gemcitabine, etoposide, dexamethasone, pegaspargase, hemophagocytic syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
gemcitabine 1.25g/㎡ d1, pegaspargase 2500IU/㎡ d1 (max dose =<3750IU) etoposide 75mg/㎡ d1-3 dexamethasone 20mg d1-4 repeated every 21 days, up to 6 cycles.
Intervention Type
Drug
Intervention Name(s)
gemcitabin
Intervention Description
1.25g/㎡ d1, repeated every 21 days
Intervention Type
Drug
Intervention Name(s)
Pegaspargase
Intervention Description
2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days
Intervention Type
Drug
Intervention Name(s)
Etoposide
Intervention Description
75mg/㎡ d1-3, repeated every 21 days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Description
20mg d1-4
Primary Outcome Measure Information:
Title
2-year progression free survival (PFS) rate
Description
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
Time Frame
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months
Secondary Outcome Measure Information:
Title
Overall response rate (ORR)
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Title
Complete response rate (CRR)
Description
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Time Frame
evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Title
2-year overall survial (OS) rate
Description
OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
Time Frame
From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 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.
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.
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, MD
Phone
+8615001108693
Email
wangliangtrhos@126.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
GPED Regimen for Relapsed/Refractory or Advanced ENKTCL
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