SIMPLE Chemotherapy for NK Lymphoma/Leukaemia

• Status: Unknown status
• Trial end date: 2020-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Treatments: Asparaginase; BB 1101; Cisplatin; Dexamethasone; Dexamethasone acetate; Etoposide; Etoposide phosphate; Gemcitabine; Ifosfamide; Isophosphamide mustard

Criteria

Inclusion Criteria:

1. Adult patients age 18-80 with biopsy proven extranodal NK/T cell lymphoma, nasal type or aggressive NK leukaemia

2. ECOG performance score <=2

Exclusion Criteria:

1. Poor performance status with ECOG >=3

2. Impairment of renal function (serum creatinine more than or equal to 200umol/L) not otherwise attributed to the tumour involvement.

3. Impairment of liver function with liver parenchymal enzymes 5 times the upper limit of normal range, not otherwise attributed to tumour involvement.