Primary Mediastinal Lymphoma
Conditions
Keywords
PET-adapted Treatment, Nivolumab at the fixed dose 40 mg, R-DA-EPOCH
Brief 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.
Interventions
DRUGCyclophosphamide
Ciclofosfamida
DRUGDoxorubicin Hydrochloride
Adriamycin
DRUGEtoposide Phosphate
Etopophos
DRUGPrednisolone
Prednisolonum
DRUGRituximab
Chimeric Anti-CD20 Antibody
DRUGVincristine Sulfate
Oncovin
DRUGFilgrastim
G-CSF
DRUGPegfilgrastim
PEG-filgrastim
Opdivo
Sponsors
National Research Center for Hematology, Russia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | From enrollment on the study to first occurrence of relapse/progression or death, assessed up to 5 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy-related event-free survival | Up to 5 years | 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. |
| Therapy-related event-free survival | Up to 5 years | 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. |
| Overall survival | Up to 5 years | 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. |
Countries
Russia
Contacts
Primary ContactYana Mangasarova, MD
Backup ContactEuvgena Zvonkov, MD,PhD
Outcome results
None listed