Clinical trial NCT04981899: 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
Official title: Multicenter 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Hodgkin Lymphoma
Keywords: Nivolumab
Ifosfamide
Carboplatin
Etoposide
Lead sponsor: St. Petersburg State Pavlov Medical University
Sponsor class: OTHER
First posted: 2021-07-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03
timeFrame: 12 months
measure: Overall Response Rate (ORR)
timeFrame: 12 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: 24 months
measure: Overall Survival (OS)
timeFrame: 24 months
measure: Progression-Free Survival (PFS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Saint Petersburg
country: Russian Federation
facility: National Medicine Research Center of oncology named after N.N. Petrov
state: Pesochny
city: Irkutsk
country: Russian Federation
facility: Irkutsk Regional Cancer Center
city: Saint Petersburg
country: Russian Federation
facility: St. Petersburg State Pavlov Medical University
Study officials:
affiliation: RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
name: Alexander Kulagin, MD,PhD
role: STUDY_DIRECTOR
References: