Phase 2 Study of Nivolumab Plus AVD for Children, Teens, and Young Adults with Hodgkin Lymphoma

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT07551583

Provider View

This clinical trial is exploring whether a combination of the drug nivolumab and chemotherapy drugs AVD can effectively treat newly diagnosed early-stage Hodgkin lymphoma in children, teens, and young adults. The study also aims to assess the safety of this treatment combination.

Patient Parameters

Program Overview

The purpose of this study is to find out if a combination of nivolumab and chemotherapy drugs (doxorubicin, vinblastine, and dacarbazine) can help control early-stage Hodgkin lymphoma in young patients. Researchers will also study the safety of this drug combination.

Description

In this study, patients will receive the following treatments:

  • Nivolumab through an IV for 30 minutes
  • Doxorubicin through an IV for 15 minutes
  • Vinblastine through an IV for 15 minutes
  • Dacarbazine through an IV for 60 minutes

These treatments will be given on days 1 and 15 of each cycle. Each cycle lasts 28 days, and patients will initially receive 2 cycles. After the second cycle, patients who show a complete response will receive 2 more cycles (cycles 3 and 4). Those with a partial response or stable disease will receive 4 more cycles (cycles 3-6). If the disease progresses or if there are unacceptable side effects, patients will stop the study treatment.

The main goals are to see how well the treatment works and to monitor any side effects. Researchers will also look at how long patients stay free of the disease and their overall survival rates.

Eligibility Criteria

Inclusion Criteria

  • Age between 2 and 21 years old.
  • Newly diagnosed with early-stage (I/II) non-bulky classical Hodgkin lymphoma.
  • Heart function with an ejection fraction over 40%.
  • Good liver function, with specific limits on bilirubin and liver enzymes unless affected by the disease.
  • Good kidney function with creatinine clearance of at least 30 mL/min.
  • General health status with an ECOG score of 2 or less.
  • No recent cancer treatments, except for certain steroids if needed.
  • Women of childbearing age must agree to use effective birth control during the study and for a period after treatment.
  • Ability to understand and sign a consent form, with parental consent if underage.

Exclusion Criteria

  • Previous treatment for lymphoma, except for certain steroids.
  • Weigh less than 10 kg.
  • Severe allergy to any study drugs.
  • Uncontrolled medical conditions or infections.
  • Currently receiving other cancer treatments.
  • Active autoimmune diseases or recent use of immunosuppressive medications, with some exceptions.
  • Use of certain medications that interact with study drugs.
  • Active HIV, hepatitis B, or hepatitis C infections, unless controlled.
  • Psychiatric or social issues that prevent following study requirements.
  • Pregnant or breastfeeding women.

Locations

FACILITYZIPCITYSTATE
UT MD Anderson77030HoustonTexas

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