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出境医 / 临床实验 / GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

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

Condition or disease Intervention/treatment Phase
Extranodal NK/T-cell Lymphoma Drug: Gemcitabine Drug: Pegaspargase Drug: Etoposide Drug: Dexamethasone Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 20, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : August 31, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: treatment arm
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
 Drug: Gemcitabine
1000mg/㎡，d1,4 ivdrip

Drug: Pegaspargase
2500IU/㎡, maximum dose less than 3750IU

Drug: Etoposide
100mg/㎡，d1-3 ivdrip

Drug: Dexamethasone
20mg/d d1-4 ivdrip
Outcome Measures
Primary Outcome Measures :
  1. overall response rate [ Time Frame: 24 weeks ±7 days ]
    evaluated by PET-CT and MRI, according to Lugano 2014 criteria


Secondary Outcome Measures :
  1. complete response rate [ Time Frame: 24 weeks ±7 days ]
    evaluated by PET-CT and MRI, according to Lugano 2014 criteria

  2. 1-year progression free survival rate [ Time Frame: up to 1year after enrollment ]
    time from date of enrollment to date of disease progression, death of any reason, whichever comes first

  3. 1-year overall survival rate [ Time Frame: up to 1year after enrollment ]
    time from date of enrollment to date death of any reason


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Contacts and Locations

Contacts
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Contact: Liang Wang, M.D. +861058268442 wangliangtrhos@126.com

Locations
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China
Beijing Tongren Hospital Recruiting
Beijing, China, 100730
Contact: Liang Wang, M.D.    +861058268442    wangliangtrhos@126.com   
Sponsors and Collaborators
Beijing Tongren Hospital
Investigators
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Principal Investigator: Liang Wang, M.D. Beijing Tongren Hospital
Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE March 20, 2020
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021) 		overall response rate [ Time Frame: 24 weeks ±7 days ]
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • complete response rate [ Time Frame: 24 weeks ±7 days ]
    evaluated by PET-CT and MRI, according to Lugano 2014 criteria
  • 1-year progression free survival rate [ Time Frame: up to 1year after enrollment ]
    time from date of enrollment to date of disease progression, death of any reason, whichever comes first
  • 1-year overall survival rate [ Time Frame: up to 1year after enrollment ]
    time from date of enrollment to date death of any reason
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Extranodal NK/T-cell Lymphoma
Intervention  ICMJE
  • Drug: Gemcitabine
    1000mg/㎡，d1,4 ivdrip
  • Drug: Pegaspargase
    2500IU/㎡, maximum dose less than 3750IU
  • Drug: Etoposide
    100mg/㎡，d1-3 ivdrip
  • Drug: Dexamethasone
    20mg/d d1-4 ivdrip
Study Arms  ICMJE Experimental: treatment arm
Treated with gemcitabine, pegaspargase, etoposide and dexamethasone
Interventions:
  • Drug: Gemcitabine
  • Drug: Pegaspargase
  • Drug: Etoposide
  • Drug: Dexamethasone
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021) 		15
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 75 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liang Wang, M.D. +861058268442 wangliangtrhos@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04917250
Other Study ID Numbers  ICMJE TRhos-ENKTCL-7
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party LIANG WANG, Beijing Tongren Hospital
Study Sponsor  ICMJE Beijing Tongren Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Liang Wang, M.D. Beijing Tongren Hospital
PRS Account Beijing Tongren Hospital
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP