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Clinical Trials in Canada / NCT04759586
Active, not recruiting Phase 3

Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma

NCT04759586 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2021-10-05
Last updated
2026-09-10

Condition(s) studied

Primary Mediastinal Large B-Cell Lymphoma

Investigational drug(s) / intervention(s)

Biospecimen CollectionBone Marrow AspirationBone Marrow BiopsyComputed TomographyCyclophosphamide →Doxorubicin Hydrochloride →Echocardiography TestEtoposide Phosphate →Filgrastim →Lumbar PunctureNivolumab →Pegfilgrastim →Positron Emission TomographyPrednisolone →Prednisone →Radiation TherapyRituximab →Rituximab and Hyaluronidase Human →Vincristine Sulfate →

Biospecimen Collection: Undergo blood and CSF sample collection

Bone Marrow Aspiration: Undergo bone marrow biopsy and aspiration

Bone Marrow Biopsy: Undergo bone marrow biopsy and aspiration

Computed Tomography: Undergo CT or PET/CT

Cyclophosphamide: Given IV

Doxorubicin Hydrochloride: Given IV

Echocardiography Test: Undergo ECHO

Etoposide Phosphate: Given IV

Filgrastim: Given SC

Lumbar Puncture: Undergo LP

Nivolumab: Given IV

Pegfilgrastim: Given SC

Positron Emission Tomography: Undergo PET/CT

Prednisolone: Given PO

Prednisone: Given PO

Radiation Therapy: Undergo radiation therapy

Rituximab: Given IV

Rituximab and Hyaluronidase Human: Given SC

Vincristine Sulfate: Given IV

Study summary

This phase III trial compares the effects of nivolumab 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.

Eligibility

Sex
ALL
Min age
2 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Age \>= 2 years * Patient must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL) as defined by World Health Organization (WHO) criteria * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 or ECOG performance status of 3 if poor performance is related to lymphoma * Children's Oncology Group (COG) Institutions: Use Karnofsky for patients \>= 17 and \< 18 years of age and Lansky for patients \< 17 years of age * Adults (age 18 or older): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight * Pediatric Patients (age \< 18 years): The following must have been obtained within 14 days prior to registration: * Measured or calculated (based on institutional standard) creatinine clearance or radioisotope glomerular filtration rate (GFR) \>= 70 ml/min/1.73 m\^2, or * Serum creatinine =\< 1.5 x institutional upper limit of normal (IULN), or a serum creatinine based on age/sex as follows: * Age : 2 to \< 6 year; Maximum serum creatinine (mg/dL): 0.8 (male; 0.8 (female) * Age : 6 to \< 10 years; Maximum serum creatinine (mg/dL): 1 (male); 1 (female) * Age : 10 to \< 13 years; Maximum serum creatinine (mg/dL): 1.2 (male); 1.2 (female) * Age : 13 to \< 16 years; Maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female) * Age : \>= 16 years to \< 18 years; Maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female) * Patients with abnormal liver function will be eligible to enroll if the lab abnormality is thought to be due to the lymphoma or Gilbert's syndrome * Age \>= 18 years: Ejection fraction of \>= 50% by echocardiogram * Age \< 18 years: Shortening fraction of \>= 27% by echocardiogram, or ejection fraction of \>= 50% by radionuclide angiogram * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * All patients and/or their parents or legal guardians must sign a written informed consent * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: * Administration of prior anti-cancer therapy except as outlined below: * A short course (=\< 2 weeks) of corticosteroids for the relief of lymphoma-related symptoms * A single course of COP (cyclophosphamide, vincristine, and prednisone) * One cycle of chemo-immunotherapy including R-CHOP, DA-EPOCH-R, a pediatric mature B-cell non-Hodgkin lymphoma (B-NHL) induction therapy (such as ANHL1131), or intrathecal chemotherapy that has not started more than 21 days prior to enrollment * Active ischemic heart disease or heart failure * Active uncontrolled infection * Central nervous system (CNS) involvement of lymphoma * Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with safety or efficacy assessment of this trial * Active autoimmune disease that has required systemic treatment (such as disease modifying agents, corticosteroids, or immunosuppressive agents) in the past 2 years. Replacement therapy such as thyroxine, insulin or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment * In patients \< 18 years of age hepatitis B serologies consistent with past or current infections * Patients with severe hepatic impairment (Child-Pugh class C or serum total bilirubin \> 5.0 mg/dL) unless thought to be due to lymphoma or Gilbert's syndrome * Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test is required for female patients of childbearing potential * Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method (failure rate of \< 1% per year when used consistently and correctly) for the duration of their study participation * Lactating females are not eligible unless they have agreed not to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last dose of rituximab

Primary outcome measure(s)

Trial sites (233)

FacilityCityRegionStatus
Children's Hospital of Alabama Birmingham Alabama
USA Health Strada Patient Care Center Mobile Alabama
Providence Alaska Medical Center Anchorage Alaska
Banner Children's at Desert Mesa Arizona
Banner University Medical Center - Tucson Tucson Arizona
Arkansas Children's Hospital Little Rock Arkansas
UC Irvine Health Cancer Center-Newport Costa Mesa California
Kaiser Permanente Downey Medical Center Downey California
City of Hope Comprehensive Cancer Center Duarte California
UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care Irvine California
City of Hope at Irvine Lennar Irvine California
Loma Linda University Medical Center Loma Linda California
Miller Children's and Women's Hospital Long Beach Long Beach California
Children's Hospital Los Angeles Los Angeles California
Cedars-Sinai Medical Center Los Angeles California
Mattel Children's Hospital UCLA Los Angeles California
Valley Children's Hospital Madera California
Kaiser Permanente-Oakland Oakland California
Children's Hospital of Orange County Orange California
UC Irvine Health/Chao Family Comprehensive Cancer Center Orange California
Lucile Packard Children's Hospital Stanford University Palo Alto California
University of California Davis Comprehensive Cancer Center Sacramento California
Rady Children's Hospital - San Diego San Diego California
Children's Hospital Colorado Aurora Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center Denver Colorado
Connecticut Children's Medical Center Hartford Connecticut
Alfred I duPont Hospital for Children Wilmington Delaware
MedStar Georgetown University Hospital Washington D.C. District of Columbia
Children's National Medical Center Washington D.C. District of Columbia
Broward Health Medical Center Fort Lauderdale Florida
Golisano Children's Hospital of Southwest Florida Fort Myers Florida
UF Health Cancer Institute - Gainesville Gainesville Florida
Memorial Regional Hospital/Joe DiMaggio Children's Hospital Hollywood Florida
Nemours Children's Clinic-Jacksonville Jacksonville Florida
University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
Arnold Palmer Hospital for Children Orlando Florida
Nemours Children's Hospital Orlando Florida
Johns Hopkins All Children's Hospital St. Petersburg Florida
Tampa General Hospital Tampa Florida
Saint Joseph's Hospital/Children's Hospital-Tampa Tampa Florida

+ 193 more sites — see the full list on the official registry below.

On this site

📄 Opdivo (nivolumab) drug profile → 📄 Deltasone (prednisone) drug profile → 📄 Rituxan (rituximab) drug profile →

More National Cancer Institute (NCI) trials in Canada

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04759586 on ClinicalTrials.gov ↗ ← All trials in Canada