GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

Extranodal NK/T-cell Lymphoma, Nasal Type Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405375
• Other study ID #: TRhos-ENKTCL-6
• Status: Recruiting
• Phase: Phase 2
• Start date: March 21, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2020
• Source: Beijing Tongren Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 29
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Extranodal NK/T-cell Lymphoma, Nasal Type
• Lymphoma
• Lymphoma, Extranodal NK-T-Cell
• Lymphoma, T-Cell

Intervention

Drug:
• gemcitabin
1.25g/? d1, repeated every 21 days
• Pegaspargase
2500IU/? d1, total dose=<3750IU, repeated every 21 days
• Etoposide
75mg/? d1-3, repeated every 21 days
• Dexamethasone
20mg d1-4

Locations

Country	Name	City	State
China	Beijing Tongren Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Tongren Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	Overall response rate (ORR)	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
Secondary	Complete response rate (CRR)	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
Secondary	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.	From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months