Nivolumab in Combination With Chemo-Immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-Cell Lymphoma (NCT04759586)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (21 items) and avoid the listed exclusions (15 items).
Location: Children's Hospital of Alabama — Birmingham, Alabama
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (233 Sites)
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.