ANHL1931: A Randomized Phase 3 trial of Nivolumab(NSC# 748726 IND# 125462) in Combination with Chemo-immunotherapy for the Treatment of Newly Diagnosed Primary Mediastinal B-cell Lymphoma

Contact:

NCT Number:

Protocol:

AAAT8617

Study Status:

Active/Enrolling

Population:

Pediatrics

Phase:

III

The purpose of this trial is to compare the effects of nivolumab with chemo- immunotherapy on people diagnosed with Primary Mediastinal B-cell lymphoma (PMBCL), an aggressive form of large B-cell lymphoma. Treatment for PMBCL involves chemotherapy combined with an immunotherapy called rituximab. These drugs effectively treat PMBCL, but are known to cause long-term side effects at high doses. Nivolumab is a type of cancer treatment which uses the immune system to fight cancer. We will be using nivolumab with chemo-immunotherapy and comparing the results with only chemo-immunotherapy in newly diagnosed PMBCL. By doing this study, we are hoping that we can figure out the best way to treat PMBCL while also improving outcomes.

Are you Eligible? (Inclusion Criteria)

  • Patients must be ≥ 2 years of age at time of initial diagnosis
  • Patients must have histologically confirmed primary mediastinal B-cell lymphoma (PMBCL)
  • Patients must meet organ function requirements as defined in the study protocol
  • Patients must also meet all other eligibility criteria as outlined in the study protocol

Specialty Area(s)

Childhood and Adolescent Cancers (Pediatric), Pediatric: Leukemia/Lymphoma, Immunotherapy

Principal Investigator

Profile Headshot
  • Section Head of Oncology, Division of Hematology, Oncology, and Stem Cell Transplant

Trial Location(s)

CUIMC/Herbert Irving Pavilion
161 Fort Washington Avenue
New York, NY 10032