Hodgkin Lymphoma
Conditions
Brief summary
A clinical study of safety and efficacy of treatment with Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma
Detailed description
A Clinical Study of Safety and Efficacy of Treatment With Nivolumab and Dexamethasone, Cytarabine and Cisplatin (DHAP) in Patients With Relapsed/Refractory Hodgkin's Lymphoma
Interventions
DRUGNivolumab
Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
Sponsors
State Budgetary Healthcare Institution, National Medical Surgical Center N.A. N.I. Pirogov, Ministry of Health of Russia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Signed informed consent * Histologically confirmed Hodgkin's lymphoma * Measurable disease (at least one lesion that can be accurately measured in at least two dimensions with spiral CT scan, min \> 15 mm in the longest diameter or \> 10 mm in the short axis) * World Health Organization (WHO) performance status \< 2 * Relapsed or refractory to at least one prior treatment line * No prior therapy with DHAP or Nivolumab * No severe concurrent illness
Exclusion criteria
* History of HIV * Active Hepatitis B or Hepatitis C infection * Uncontrolled infection (requiring intravenous treatment) at the time of enrollment * Pregnancy or breastfeeding * Somatic or psychiatric disorder making the patient unable to sign informed consent * Active or prior documented autoimmune disease requiring systemic treatment * No receiving a live vaccine within 30 days prior to first dose of nivolumab * History of non-infectious pneumonitis that required steroids * Other malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) of Nivolumab and DHAP in patients with relapsed/refractory Hodgkin's lymphoma | up to 6 months | Overall response rate (ORR), defined as proportion of patients with complete response (CR) or partial response (PR) in measurable lesions as defined by Lugano classification 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 6 months | Toxicity parameters based on NCI CTCAE 4.03 grades |
| Progression-Free Survival | up to 12 months | — |
| Overall Survival | up to 12 months | — |
Countries
Russia
Outcome results
None listed