SIMPLE Chemotherapy for NK Lymphoma/Leukaemia

NCT03623087 | Unknown Phase 3

• 1 other identifier: NK-002
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Efficacy as measured by overall response rate measured at the time of best response.

  Overall response rate (ORR) is defined as the proportion of patients with reduction in tumor burden of at least 50%.

  2 years

Secondary Outcomes (3)

• Adverse events and severe adverse events related to the treatment

  1 year

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

SIMPLE

EXPERIMENTAL

cisplatin, gemcitabine, ifosfamide, etoposide (VP-16), L-asparaginase, dexamethasone

Drug: Cisplatin; Drug: Gemcitabine; Drug: Etoposide (VP-16); Device: Ifosfamide; Drug: Dexamethasone; Drug: L-asparaginase

Interventions

Cisplatin DRUG

SIMPLE

SIMPLE

Gemcitabine DRUG

SIMPLE

SIMPLE

Etoposide (VP-16) DRUG

SIMPLE

SIMPLE

Ifosfamide DEVICE

SIMPLE

SIMPLE

Dexamethasone DRUG

SIMPLE

SIMPLE

L-asparaginase DRUG

SIMPLE

SIMPLE

Eligibility Criteria

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

You may qualify if:

• Adult patients age 18-80 with biopsy proven extranodal NK/T cell lymphoma, nasal type or aggressive NK leukaemia
• ECOG performance score \<=2

You may not qualify if:

• Poor performance status with ECOG \>=3
• Impairment of renal function (serum creatinine more than or equal to 200umol/L) not otherwise attributed to the tumour involvement.
• Impairment of liver function with liver parenchymal enzymes 5 times the upper limit of normal range, not otherwise attributed to tumour involvement.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Recurrence

Interventions

Cisplatin; Gemcitabine; Etoposide; Dexamethasone; Asparaginase

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Podophyllotoxin; Tetrahydronaphthalenes; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Glucosides; Glycosides; Carbohydrates; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Steroids, Fluorinated; Amidohydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Study Officials

• Yok Lam Kwong, MBBS

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Thomas Chan, MBBS

CONTACT

852-22553456; thomas28@netvigator.com

Crosby Lu, MMedSc

CONTACT

852-22551654; khlu@hku.hk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair Professor

Study Record Dates

• First Submitted: July 25, 2018
• First Posted: August 9, 2018
• Study Start: July 1, 2017
• Primary Completion: March 14, 2020
• Study Completion: June 30, 2020
• Last Updated: August 14, 2018

Record last verified: 2018-08

Locations

HK (1)