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

Conditions

• NK/T Cell Lymphoma

Eligibility Criteria

Sex

ALL

Age

21 Years - 80 Years

Healthy Volunteers

Not accepted

Interventions

• IV Nivolumab — DRUG
  240mg every 2 weeks.
• IV Nivolumab — DRUG
  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.
• IV Gemcitabine — DRUG
  800mg/m2 on Days 1 and 8 every 21 days
• IV Cisplatin — DRUG
  20mg/m2 on Day 1 to 4 every 21 days
• IV/PO Dexamethasone — DRUG
  10mg on Days 1 to 4 every 21 days
• IV L-asparaginase — DRUG
  6000 Units/m2 on Days 2 to 8 every 21 days

Study Details

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.

Key Dates

Start date

Dec 12, 2019

Status verified

Nov 2020

Primary completion

Jun 12, 2020

Completion

Jun 12, 2020

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Nivolumab
  After 4 doses of nivolumab, if the patient has complete responses (CR) or good partial response (PR), the patient will continue on nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment. During PET4-directed treatment with single agent nivolumab, if patient has PD, they will proceed to the Nivo+GDP/L-aspa arm.
• Experimental: Nivolumab + GDP/ L-asparaginase
  After 4 doses of nivolumab, if the patient has PR, stable disease (SD), or progressive disease (PD), the patient will switch to nivolumab-GDP/L-aspa treatment. After 6 cycles of treatment, if CR is achieved, the patient will continue on single agent nivolumab until disease progression, unacceptable toxicities, or discontinuation of treatment.

Primary Outcome Measure

Number of patients with complete response and partial response to treatment [ Time Frame: 6 months after the start of treatment ]