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

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 GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Study Overview

• Status: Recruiting
• Conditions: Extranodal NK/T-cell Lymphoma
• Intervention / Treatment: Drug: Gemcitabine; Drug: Pegaspargase; Drug: Etoposide; Drug: Dexamethasone

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Liang Wang, M.D.; Phone Number: +861058268442; Email: wangliangtrhos@126.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Beijing Tongren Hospital
    • Contact: Liang Wang, M.D.; Phone Number: +861058268442; Email: wangliangtrhos@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 75 years (Child, 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. 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall response rate	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complete response rate	evaluated by PET-CT and MRI, according to Lugano 2014 criteria	24 weeks ±7 days
1-year progression free survival rate	time from date of enrollment to date of disease progression, death of any reason, whichever comes first	up to 1year after enrollment
1-year overall survival rate	time from date of enrollment to date death of any reason	up to 1year after enrollment

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital
• Investigators: Principal Investigator: Liang Wang, M.D., Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2020
• Primary Completion (Anticipated): June 30, 2021
• Study Completion (Anticipated): August 31, 2021

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2021
• Last Update Submitted That Met QC Criteria: June 2, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Extranodal NK-T-Cell; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Autonomic Agents; Peripheral Nervous System Agents; Antiviral Agents; Enzyme Inhibitors; Anti-Inflammatory Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Antineoplastic Agents, Phytogenic; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Gemcitabine; Dexamethasone; Etoposide; Pegaspargase
• Other Study ID Numbers: TRhos-ENKTCL-7

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