GLIDE Regimen Followed by ASCT for Aggressive NK/T Cell Lymphoma

NCT03154918 | Unknown Phase 2

• 1 other identifier: HXNKT 1.0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to explore the efficacy and safety of GLIDE regiment in patients with aggressive NK/T cell lymphoma.

Conditions

Lymphoma, Extranodal NK-T-Cell

Outcome Measures

Primary Outcomes (1)

• PFS

  2-year progression free survival

  2 years after recruitment

Secondary Outcomes (3)

• CR

  2 and 6 month after GLIDE, and 3 month after ASCT

• AEs

  2 years after recruitment

• OS

  2 years after recruitment

Study Arms (1)

GLIDE

EXPERIMENTAL

Treated with GLIDE regiment chemotherapy for 4 cycles.

Drug: GLIDE

Interventions

GLIDE DRUG

The dose and schedule of GLIDE chemotherapy was as follows: gemcitabine 800 mg/m 2 days 1, 8; Peg-ASP 2500 U/m 2 days 4; ifosfamide 1000 mg/m 2 days 1 - 3; dexamethasone 20 mg days 1 - 4; etoposide 100 mg/m 2 days 1 - 3.

Also known as: gemcitabine,Peg-ASP,ifosfamide,dexamethasone and etoposide

GLIDE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of ENKL defined by World Health Organization classification 2008;
• age above 18 years;
• Eastern Cooperative Oncology Group performance status of 0-3;
• adequate organ function defined as: total bilirubin≤2 times the upper limit of normal; alanine aminotransferase and aspartate aminotransferase levels≤2.5 times the upper limit of normal; serum creatinine≤1.5 mg/dL; creatinine clearance ≥50 mL/minute and normal electrocardiogram results.

You may not qualify if:

• uncontrolled infection;
• pregnant or lactating women;
• contraindication to one of the trial drugs (eg. anaphylaxis to L-asparaginase);
• any coexisting medical problems of sufficient severity to prevent full compliance with the study protocol

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610044, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-Cell

Interventions

Dexamethasone; Etoposide

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Glucosides; Glycosides; Carbohydrates

Study Officials

• Ting Liu, MD

  West China Hospital

  STUDY DIRECTOR

Central Study Contacts

Jie Ji, MD

CONTACT

86-28-85422370; jieji@scu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 16, 2017
• Study Start: June 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: March 30, 2021
• Last Updated: November 8, 2017

Record last verified: 2017-11

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)