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

Phase 2Active Not RecruitingNCT04981899

St. Petersburg State Pavlov Medical University30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis: Histologically confirmed Hodgkins lymphoma * Relapsed or refractory disease after the first line of treatment * Age 18-70 years old * Ejection fraction greater than 50% * ECOG 0-2 status * Signed informed consent * No severe concurrent illness Exclusion Criteria: * Uncontrolled bacterial or fungal infection at the time of enrollment * Requirement for vasopressor support at the time of enrollment * Severe organ failure: creatinine more than 2 norms; ALT, AST more than 5 norms; bilirubin more than 1.5 norms * Karnofsky index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign an informed consent * Active or prior documented autoimmune disease requiring systemic treatment.

Locations (3)

St. Petersburg State Pavlov Medical University

Saint Petersburg, Northwestern Federal District, Russia

National Medicine Research Center of oncology named after N.N. Petrov

Saint Petersburg, Pesochny, Russia

Irkutsk Regional Cancer Center

Irkutsk, Russia

Outcomes

Primary Outcomes

Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03

Toxicity parameters based on NCI CTCAE 4.03 grades: hematological toxicity (CBC), hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), fatigue (attending physician assessment), rash (attending physician assessment), colitis (attending physician assessment), pneumonitis (attending physician assessment), autoimmune disorders (level of hormones, presence of autoimmune antibodies, attending physician assessment).

Time frame: 12 months

Overall Response Rate (ORR)

Overall response rate (ORR), defined as the proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC and Lugano 2014 criteria

Time frame: 12 months

Secondary Outcomes

Duration of Response (DOR)

Time frame: 24 months

Overall Survival (OS)

Time frame: 24 months

Progression-Free Survival (PFS)

Time frame: 24 months

Progression-Free Survival Rate (Post Autologous Transplant)

PFS is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first.

Time frame: 24 months

Overall Survival (Post Autologous Transplant)

OS is defined as the duration of time from start of transplant to time of death (due to any cause).

Time frame: 24 months