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

Hodgkin Lymphoma Clinical Trial

— NICE-40  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04981899
• Other study ID #: r/r cHL NICE-40
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 1, 2021
• Est. completion date: October 1, 2024

Study information

• Verified date: April 2023
• Source: St. Petersburg State Pavlov Medical University
• Contact: Kirill Lepik, MD,PhD
• Phone: +78123386265
• Email: lepikkv[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Irkutsk Regional Cancer Center	Irkutsk
Russian Federation	National Medicine Research Center of oncology named after N.N. Petrov	Saint Petersburg	Pesochny
Russian Federation	St. Petersburg State Pavlov Medical University	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
St. Petersburg State Pavlov Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months
Primary	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	12 months
Secondary	Duration of Response (DOR)		24 months
Secondary	Overall Survival (OS)		24 months
Secondary	Progression-Free Survival (PFS)		24 months