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

Primary Mediastinal Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06188676
• Other study ID #: PMBL-2022
• Status: Recruiting
• Phase: Phase 3
• Start date: April 1, 2022
• Est. completion date: April 1, 2029

Study information

• Verified date: December 2023
• Source: National Research Center for Hematology, Russia
• Contact: Yana Mangasarova, MD
• Phone: +74956122361
• Email: v.k.jana[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: April 1, 2029
• Est. primary completion date: April 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Primary Mediastinal Lymphoma

Intervention

Drug:
• Cyclophosphamide
Ciclofosfamida
• Doxorubicin Hydrochloride
Adriamycin
• Etoposide Phosphate
Etopophos
• Prednisolone
Prednisolonum
• Rituximab
Chimeric Anti-CD20 Antibody
• Vincristine Sulfate
Oncovin
• Filgrastim
G-CSF
• Pegfilgrastim
PEG-filgrastim
• Nivolumab 40 mg in 4 ml Injection
Opdivo

Locations

Country	Name	City	State
Russian Federation	National Research Center for Hematology	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Hematology, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	The primary analysis will be a one-sided Log-rank test stratified by choice of backbone and radiation therapy and whether the patient had a cycle of therapy prior to enrolling.	From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years
Secondary	Efficacy-related event-free survival	Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.	Up to 5 years
Secondary	Therapy-related event-free survival	Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as progression, change in therapy due to a finding that led to concern about efficacy, biopsy + disease after 6 cycles of therapy, and death.	Up to 5 years
Secondary	Overall survival	Will be analyzed using a one-sided stratified Log-rank test at alpha = 0.05 or 0.025, as appropriate, with events defined as only death.	Up to 5 years