Multicenter Study of Safety and Efficacy Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed PMBL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cyclophosphamide, Doxorubicin Hydrochloride, Etoposide Phosphate, Prednisolone.
- Who it may be relevant to
- Registry conditions: Primary Mediastinal Lymphoma. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Russia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Nivolumab at the Fixed Dose 40 mg (Nivo40) in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma
Overview
This compares the effects of nivolumab at a fixed dose of 40 mg with chemo-immunotherapy versus chemo-immunotherapy alone in treating patients with newly diagnosed primary mediastinal B-cell lymphoma (PMBCL). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of cancer cells to grow and spread. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving nivolumab with chemo-immunotherapy may help treat patients with PMBCL.
Interventions
- Drug Cyclophosphamide
Ciclofosfamida - Drug Doxorubicin Hydrochloride
Adriamycin - Drug Etoposide Phosphate
Etopophos - Drug Prednisolone
Prednisolonum - Drug Rituximab
Chimeric Anti-CD20 Antibody - Drug Vincristine Sulfate
Oncovin - Drug Filgrastim
G-CSF - Drug Pegfilgrastim
PEG-filgrastim - Drug Nivolumab 40 mg in 4 ml Injection
Opdivo
Primary outcome measures
- Progression-free survival (PFS) [Time frame: From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years]
Secondary outcome measures (3)
- Efficacy-related event-free survival [Time frame: Up to 5 years]
- Therapy-related event-free survival [Time frame: Up to 5 years]
- Overall survival [Time frame: Up to 5 years]
Eligibility criteria
Inclusion criteria
\- Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria Age 18-70 years old Ejection fraction greater than 50% ECOG 0-2 status Signed informed consent No severe concurrent illness measurable disease (at least one lesion that can be accurately measured in at least two dimensions on a CT scan, at least >15 mm in largest diameter
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Russia · 1 center
- National Research Center for Hematology — Moscow
Identifiers
NCT: NCT06188676 · PMBL-2022