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
NCT ID: NCT06188676
Last Updated: 2024-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
100 participants
INTERVENTIONAL
2022-04-01
2029-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A
Active Comparator: Arm A (DA-EPOCH-R) Patients receive prednisone or prednisolone on days 1-5 and rituximab IV or rituximab and hyaluronidase human SC over 5 minutes on day 1 or 5. Patients also receive etoposide phosphate, doxorubicin hydrochloride, and vincristine sulfate IV over 96 hours on days 1-4 and cyclophosphamide IV over 30-60 minutes on day 5. Beginning 24-72 hours after completing cyclophosphamide, patients receive filgrastim or pegylated filgrastim SC daily until ANC is \>= 500/uL after the expected nadir. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT on study. When СR is achieved according to PET / CT after 4 cycles of chemotherapy, 2 randomization is performed, a total of 4 or 6 chemotherapy courses
Cyclophosphamide
Ciclofosfamida
Doxorubicin Hydrochloride
Adriamycin
Etoposide Phosphate
Etopophos
Prednisolone
Prednisolonum
Rituximab
Chimeric Anti-CD20 Antibody
Vincristine Sulfate
Oncovin
Filgrastim
G-CSF
Pegfilgrastim
PEG-filgrastim
B
(DA-EPOCH-R, nivolumab) Patients receive treatment as in Arm A. Patients also receive nivolumab 40 mg IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 6 cycles (5 if the patient had 1 prior cycle of treatment) in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET/CT on study. When СR is achieved according to PET / CT after 4 cycles of chemotherapy, 2 randomization is performed, a total of 4 or 6 chemotherapy courses.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
70 Years
ALL
No
Sponsors
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National Research Center for Hematology, Russia
NETWORK
Responsible Party
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Elena N.Parovichnikova
Vice-director Nathional Medical Research Center for Hematology Moscow Russia
Principal Investigators
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Elena Parovichnikova, MD,PhD
Role: STUDY_DIRECTOR
Nathional Medical Research Center for Hematology Moscow Russia 125167
Locations
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National Research Center for Hematology
Moscow, , Russia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PMBL-2022
Identifier Type: -
Identifier Source: org_study_id
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