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A Study of Safety and Efficacy of PET-adapted Treatment With Nivolumab at the Fixed Dose 40 mg, Ifosfamide, Carboplatin, Etoposide (NICE-40) in Patients With Relapsed/Refractory Hodgkin Lymphoma

NCT04981899 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2023-04-12

No results posted yet for this study

Summary

Nivolumab is an anti-PD-1 antibody highly effective in patients with relapsed/refractory classical Hodgkin lymphoma. A PET-adapted regimen of Nivo combined with ICE as first salvage therapy was shown to induce high response rates and favorable progression-free survival as a bridge to autologous stem cell transplantation, allowing to omit salvage chemotherapy in a substantial proportion of r\\r cHL patients. This study evaluates the safety and efficacy of PET-adapted treatment of nivolumab at the fixed dose of 40 mg in combination with ifosfamide, carboplatin, and etoposide (NICE-40) in patients with relapsed/refractory Hodgkin Lymphoma.

Conditions

Interventions

DRUG

Nivolumab

6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.

DRUG

Ifosfamide

5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.

DRUG

Carboplatin

Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.

DRUG

Etoposide

100 mg / m2 intravenously on 1-3 days of the NICE-40.

Sponsors & Collaborators

  • St. Petersburg State Pavlov Medical University

    lead OTHER

Principal Investigators

  • Alexander Kulagin, MD,PhD · RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-01
Primary Completion
2023-10-01
Completion
2024-10-01

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

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 NCT04981899 on ClinicalTrials.gov