GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

May 24, 2020 updated by: JING-WEN WANG, Beijing Tongren Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

29

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100730
        • Recruiting
        • Beijing Tongren Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: treatment arm
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.
Drug: gemcitabin
1.25g/㎡ d1, repeated every 21 days
Drug: Pegaspargase
2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days
Drug: Etoposide
75mg/㎡ d1-3, repeated every 21 days
Drug: Dexamethasone
20mg d1-4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
2-year progression free survival (PFS) rate
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
PFS is defined as date of enrollment to date of disease progression, relapse, death of any reason, or last follow-up, whichever comes first.
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 Measures

Outcome Measure
Measure Description
Time Frame
Overall response rate (ORR)
Time Frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
evaluated every 2 cycles of treamtent, up to one month after the end of treatment
Complete response rate (CRR)
Time Frame: evaluated every 2 cycles of treamtent, up to one month after the end of treatment
evaluated by PET-CT and MRI, according to Lugano 2014 criteria
evaluated every 2 cycles of treamtent, up to one month after the end of treatment
2-year overall survial (OS) rate
Time Frame: From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months
OS is defined as date of enrollment to date of death of any reason, or last follow-up, whichever comes first.
From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Tongren Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 21, 2020

Primary Completion (ANTICIPATED)

April 30, 2023

Study Completion (ANTICIPATED)

April 30, 2023

Study Registration Dates

First Submitted

May 24, 2020

First Submitted That Met QC Criteria

May 24, 2020

First Posted (ACTUAL)

May 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 28, 2020

Last Update Submitted That Met QC Criteria

May 24, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRhos-ENKTCL-6

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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