Hodgkin's Lymphoma
Conditions
Keywords
Hodgkin's Lymphoma, Nivolumab, Bendamustine Hydrochloride
Brief summary
A clinical study of safety and efficacy of treatment with Nivolumab and Bendamustine (NB) in patients with relapsed/refractory Hodgkin's lymphoma.
Interventions
DRUGNivolumab
3 mg/kg IV infusion on day 1,14 up to 3 cycles
DRUGBendamustine Hydrochloride
90 mg/kg IV infusion on day 1 up to 3 cycles
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 Hodgkin's lymphoma * Relapsed or refractory to at least two prior treatment lines * Relapsed after nivolumab treatment or refractory to nivolumab 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) of Nivolumab in combination with Bendamustine Hydrochloride in patients with Hodgkin's lymphoma | up to 3 months | Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by LYRIC criteria and duration of response. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of grade 3 or higher treatment-related adverse events by CTCAE 4.03 | up to 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) | up to 12 months | Duration of response will be measured from the time of initial response to nivolumab till documented disease progression, death or last evaluation of tumor status. |
| Time to Progression (TTP) | up to 12 months | — |
| Progression-Free Survival (PFS) | up to 12 months | — |
| Overall Survival (OS) | up to 12 months | — |
Countries
Russia
Outcome results
None listed