Hodgkin Lymphoma
Conditions
Keywords
Nivolumab
Brief summary
A phase I/II trial to evaluate the safety and efficacy of nivolumab at the fixed dose 40 mg in patients with relapsed or refractory Hodgkins lymphoma.
Interventions
40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days
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 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis: Histologically confirmed Hodgkins lymphoma * Relapsed or refractory disease after at least two prior lines of treatment * Age 18-70 years old * 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 * Karnofsky index \<30% * Pregnancy * Somatic or psychiatric disorder making the patient unable to sign informed consent * Active or prior documented autoimmune disease requiring systemic treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 criteria |
Secondary
| 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). |
| Duration of Response (DOR) | 12 months | — |
| Progression-Free Survival (PFS) | 12 months | — |
| Overall Survival (OS) | 12 months | — |
Countries
Russia
Outcome results
None listed