NCT04405375

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2020

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 21, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 28, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

May 28, 2020

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

May 24, 2020

Last Update Submit

May 24, 2020

Conditions

Extranodal NK/T-cell Lymphoma, Nasal Type

Keywords

extranodal NK/T-cell lymphomagemcitabineetoposidedexamethasonepegaspargasehemophagocytic syndrome

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Overall response rate (ORR)

    evaluated every 2 cycles of treamtent, up to one month after the end of treatment

  • Complete response rate (CRR)

    evaluated every 2 cycles of treamtent, up to one month after the end of treatment

  • 2-year overall survial (OS) rate

    From date of enrollment until the date of death from any cause or last follow-up, assessed up to 24 months

Study Arms (1)

treatment arm

EXPERIMENTAL

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: gemcitabinDrug: PegaspargaseDrug: EtoposideDrug: Dexamethasone

Interventions

gemcitabinDRUG

1.25g/㎡ d1, repeated every 21 days

treatment arm
PegaspargaseDRUG

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

treatment arm
EtoposideDRUG

75mg/㎡ d1-3, repeated every 21 days

treatment arm
DexamethasoneDRUG

20mg d1-4

treatment arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing Tongren Hospital

Beijing, 100730, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, Extranodal NK-T-CellLymphohistiocytosis, Hemophagocytic

Interventions

GemcitabinepegaspargaseEtoposideDexamethasone

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsHistiocytosis, Non-Langerhans-CellHistiocytosisLymphatic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingPodophyllotoxinTetrahydronaphthalenesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic CompoundsGlucosidesGlycosidesCarbohydratesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsSteroids, Fluorinated

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
Director of department of hematology

Study Record Dates

First Submitted

May 24, 2020

First Posted

May 28, 2020

Study Start

March 21, 2020

Primary Completion

April 30, 2023

Study Completion

April 30, 2023

Last Updated

May 28, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)