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SIMPLE Chemotherapy for NK Lymphoma/Leukaemia

NCT03623087 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2018-08-14

No results posted yet for this study

Summary

NK malignancies consist of two different clinical entities, extranodal NK/T cell lymphoma and aggressive NK leukaemia. Queen Mary Hospital (QMH) had started to use PIGLETS chemotherapy for treatment of NK malignancies since 2013, with promising results. The study in QMH had ended because of successful recruitment in the planned number of subjects.

When PIGLETS was used in extranodal NK/T cell lymphoma, patients with stage I/II lymphoma have an overall response rate of nearly 90%, while patients with stage III/IV disease have an overall response rate of around 60%. The figures are comparable to the SMILE chemotherapy previously used. However, PIGLETS regimen carries much lower risk of nephrotoxicity when compared with SMILE. It has since become a standard protocol in management of NK malignancies in our institution.

PIGLETS chemotherapy carries two major problems:

1. the name PIGLETS may appear offensive to some religious populations. (e.g. Muslim)
2. significant nausea/vomiting was seen in previous studies, and these could at least be partially alleviated with substance P antagonist aprepitant

Thus the investigators decided to start a study, renaming the original PIGLETS regimen into SIMPLE chemotherapy, adding aprepitant as antiemetics and to recruit more patients for evaluation of clinical efficacy. The results of SIMPLE chemotherapy will be compared to SMILE in a non-inferiority trial setting.

Conditions

  • Non-Hodgkin's Lymphoma, Relapsed
  • Non-Hodgkin T-cell Lymphoma
  • Natural Killer/T-Cell Lymphoma, Nasal and Nasal-Type

Interventions

DRUG

Cisplatin

SIMPLE

DRUG

Gemcitabine

SIMPLE

DRUG

Etoposide (VP-16)

SIMPLE

DEVICE

Ifosfamide

SIMPLE

DRUG

Dexamethasone

SIMPLE

DRUG

L-asparaginase

SIMPLE

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yok Lam Kwong, MBBS · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-01
Primary Completion
2020-03-14
Completion
2020-06-30

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03623087 on ClinicalTrials.gov