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

Sponsor
St. Petersburg State Pavlov Medical University
Study ID
NCT04981899
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Nivolumab — DRUG
    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.
  • Ifosfamide — DRUG
    5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
  • Carboplatin — DRUG
    Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
  • Etoposide — DRUG
    100 mg / m2 intravenously on 1-3 days of the NICE-40.

Study Details

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.

Key Dates

Start date
Mar 1, 2021
Status verified
Apr 2023
Primary completion
Oct 1, 2023
Completion
Oct 1, 2024

Study Design

Enrollment
30 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Main arm
    Patients will receive 6 cycles of nivolumab at the fixed dose of 40 mg, with subsequent assessment of response by PET-CT. Patients with CR will proceed to ASCT. Patients with \<CR after nivolumab monotherapy will be treated with 2 cycles of a combination of nivolumab at the fixed dose 40 mg, ifosfamide, carboplatin and etoposide (NICE-40), with subsequent PET-CT assessment.

Primary Outcome Measure

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 [ Time Frame: 12 months ]

Central Contacts

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