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PhIII InterRespAdapTriaCompStandTherpW/Immuno-OncologyTherpChild&AdultDxStagI&IIClassHodgkinLymph

UCI Specialty Area: Cancer
Principal Investigator: Nicole Foley
Official Title: A Randomized Phase III Interim Response Adapted Trial Comparing Standard Therapy with Immuno-oncology Therapy for Children and Adults with Newly Diagnosed Stage I and II Classical Hodgkin Lymphoma
A Study On:
Hodgkin's Lymphoma

Study Description

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride 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. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

Eligibility

NOTE: This is NOT a comprehensive list of eligibility criteria. The list below describes key eligibility criteria for prospective study participants. A complete list of eligibility criteria will be available in the informed consent form.

Key inclusion criteria:

  1. Patients with newly diagnosed, untreated, histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified (NOS)) with Stage I or II disease.
  1. Patients who are clinically diagnosed with HIV, who are currently taking effective anti-retroviral treatment with undetectable viral load within the last 6 months are eligible.
  1. Patients who are diagnosed with chronic Hepatitis B infection must have an undetectable viral load on suppressive therapy, if indicated, to be eligible.
  1. Patients who have a clinical history of Hepatitis C (HCV) infection must either (a) have been treated and cured, OR (b) if currently being treated for HCV, must have an undetectable viral load to be eligible.
  1. Patients must demonstrate adequate organ function, defined and classified clearly in the informed consent form.

Key exclusion criteria:

  1. Patients with nodular lymphocyte predominant Hodgkin Lymphoma are not eligible.
  1. Patients who are diagnosed with inherited OR acquired immunodeficiency that is either (a) poorly controlled OR (b) requires active medications, such as primary immunodeficiency syndromes or organ transplant recipients, are not eligible.
  1. Patients who received at least one of the following therapies:

(a) prior chemotherapy, radiation, or antibody-based treatment for cHL,

(b) prior solid organ transplant,

(c) prior allogenic stem cell transplants, or

(d) a live vaccine within 30 days prior to the first day of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, BCG, oral polio vaccine, and oral typhoid); mRNA vaccines ARE permitted.

  1. Female patients who are currently pregnant are not eligible to participate due to the study drugs' indication of fetal and teratogenic toxicities. A pregnancy test taken within 28 days of enrollment is required for all female patients of childbearing potential.
  1. Sexually active patients of reproductive potential who have not agreed to highly effective means of contraception are not eligible.
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Privacy Policy

University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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