GPED Regimen for Relapsed/Refractory or Advanced ENKTCL

NCT ID: NCT04405375

Last Updated: 2020-05-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-21
• Study Completion Date: 2023-04-30

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.

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

gemcitabin

Intervention Type: DRUG

1.25g/㎡ d1, repeated every 21 days

Pegaspargase

Intervention Type: DRUG

2500IU/㎡ d1, total dose=\<3750IU, repeated every 21 days

Etoposide

Intervention Type: DRUG

75mg/㎡ d1-3, repeated every 21 days

Dexamethasone

Intervention Type: DRUG

20mg d1-4

Interventions

gemcitabin

1.25g/㎡ d1, repeated every 21 days

Intervention Type: DRUG

Pegaspargase

2500IU/㎡ d1, total dose=\<3750IU, repeated every 21 days

Intervention Type: DRUG

Etoposide

75mg/㎡ d1-3, repeated every 21 days

Intervention Type: DRUG

Dexamethasone

20mg d1-4

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tongren Hospital

OTHER

Sponsor Role: lead

Responsible Party

JING-WEN WANG

Director of department of hematology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tongren Hospital

Beijing, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Liang Wang, MD

Role: primary

wangliangtrhos@126.com

+8615001108693

Other Identifiers

TRhos-ENKTCL-6

Identifier Type: -

Identifier Source: org_study_id