Actively Recruiting
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
Led by National Research Center for Hematology, Russia · Updated on 2024-01-03
100
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by WHO criteria
- Age between 18 and 70 years old
- Ejection fraction greater than 50%
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
- Signed informed consent
- Measurable disease with at least one lesion accurately measurable on CT scan at least 15 mm in largest diameter
- No severe concurrent illness
You will not qualify if you...
- Uncontrolled bacterial or fungal infection at enrollment
- Requirement for vasopressor support at enrollment
- Severe organ failure: creatinine more than twice normal; ALT or AST more than 5 times normal; bilirubin more than 1.5 times normal
- Karnofsky index less than 30%
- Pregnancy
- Somatic or psychiatric disorder preventing informed consent
- Active or prior autoimmune disease requiring systemic treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Research Center for Hematology
Moscow, Russia, 125167
Actively Recruiting
Research Team
Y
Yana Mangasarova, MD
CONTACT
E
Euvgena Zvonkov, MD,PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here