Hodgkin Lymphoma
Conditions
Keywords
Nivolumab, Ifosfamide, Carboplatin, Etoposide
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.
Interventions
DRUGNivolumab
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.
DRUGIfosfamide
5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
DRUGCarboplatin
Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
DRUGEtoposide
100 mg / m2 intravenously on 1-3 days of the NICE-40.
Sponsors
St. Petersburg State Pavlov Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 | 12 months | 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). |
| Overall Response Rate (ORR) | 12 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Response (DOR) | 24 months | — |
| Overall Survival (OS) | 24 months | — |
| Progression-Free Survival (PFS) | 24 months | — |
| Progression-Free Survival Rate (Post Autologous Transplant) | 24 months | PFS is defined as the duration of time from start of transplant to time of progression or death, whichever occurs first. |
| Overall Survival (Post Autologous Transplant) | 24 months | OS is defined as the duration of time from start of transplant to time of death (due to any cause). |
Countries
Russia
Contacts
STUDY_DIRECTORAlexander Kulagin, MD,PhD
RM Gorbacheva Research Institute of Pediatric Oncology, Hematology and Transplantation, Pavlov University
Outcome results
None listed