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Nivolumab in Combination With GDP/ L-asparaginase in NK/ T-cell Lymphoma

NCT04230330 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2020-11-05

No results posted yet for this study

Summary

This is a pilot study investigating the role of nivolumab, a PD-1 inhibitor, in the treatment of advanced stage or relapsed/refractory NKTL. Patients who have received PD-1 inhibitors will be excluded from this study.

Patients who have a complete response or good partial response to nivolumab during initial phase will continue to be treated with nivolumab. Patients who have a partial response, stable disease, and progressive disease to nivolumab during initial phase will be treated with the combination of nivolumab and GDP/L-asparaginase.

Conditions

  • NK/T Cell Lymphoma

Interventions

DRUG

IV Nivolumab

240mg every 2 weeks.

DRUG

IV Nivolumab

Initial treatment dose is 240mg every 2 weeks for 4 doses. Dose changes to 360mg every 3 weeks when given with GDP/L-aspa. Maintenance treatment dose is 240mg every 2 weeks.

DRUG

IV Gemcitabine

800mg/m2 on Days 1 and 8 every 21 days

DRUG

IV Cisplatin

20mg/m2 on Day 1 to 4 every 21 days

DRUG

IV/PO Dexamethasone

10mg on Days 1 to 4 every 21 days

DRUG

IV L-asparaginase

6000 Units/m2 on Days 2 to 8 every 21 days

Sponsors & Collaborators

Principal Investigators

  • Tiffany Tang, MD · National Cancer Centre, Singapore

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2020-06-12
Completion
2020-06-12

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Companies

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 NCT04230330 on ClinicalTrials.gov