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For pediatric classical Hodgkin lymphoma
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How may I benefit from ADCETRIS?

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AHOD1331 study design

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AHOD1331 was a large clinical study of 600 children 2 years and older that compared the effectiveness and safety of ADCETRIS plus AVEPC with ABVEPC chemotherapy in patients with previously untreated classical Hodgkin lymphoma.

  • 300 pediatric patients were assigned to receive ADCETRIS plus AVEPC every 3 weeks for up to 5 cycles
  • 300 pediatric patients were assigned to receive ABVEPC chemotherapy every 3 weeks for up to 5 cycles


Patients ranged in age from 3 to 21 years; the median age was 15. High risk was defined as Ann Arbor Stage 2B with bulk disease, Stage 3B, Stage 4A, and Stage 4B. Researchers observed the event-free survival results (primary endpoint) at a median follow-up time of just over 3.5 years (42.1 months).

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Event-free survival results

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Approximately 3.5 years after enrolling in the study, more pediatric patients treated with ADCETRIS plus AVEPC did not have their cancer grow, spread, or come back, receive a separate cancer diagnosis, or die compared to ABVEPC chemotherapy.

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After 3 years, it was estimated that about 92% of the 300 pediatric patients treated with ADCETRIS plus AVEPC did not have their cancer grow, spread, or come back, receive a separate cancer diagnosis, or die compared to about 83% of the 300 pediatric patients treated with ABVEPC chemotherapy.
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Study Results
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Side Effects
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What safety information should I know about ADCETRIS?

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The most important serious safety information

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PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML): Patients treated with ADCETRIS can have a rare, serious brain infection called PML that can lead to death. Tell your doctor immediately if you have mood or behavior changes, confusion, problems in thinking or loss of memory, changes in vision, speech, or walking, or decreased strength or weakness on one side of the body. PML may also be caused by prior treatments or diseases that weakened your immune system.

Do not take ADCETRIS with bleomycin because of possible serious side effects to the lungs. These are not the only side effects of ADCETRIS. Always tell your doctor about any side effects you experience
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Most common severe side effects while taking ADCETRIS plus AVPEC

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In pediatric patients treated with ADCETRIS plus AVEPC, the most common severe side effects that occurred in ≥5% of study patients were low number of red blood cells (35%), low number of white blood cells with a fever (28%), low number of white blood cells called lymphocytes (13%), low platelet count (10%), sores or swelling in the mouth (10%), infection (9%), low number of white blood cells called neutrophils (8%), nerve damage (peripheral sensory neuropathy; PN) (6%), and low potassium level in the blood (5%).

Serious adverse reactions occurred in 22% of patients who received ADCETRIS plus AVEPC chemotherapy. The most common serious side effects were low blood pressure (3%) and significantly low numbers of white blood cells with a fever (3%)

For more information on side effects, please see the Important Safety Information at the bottom of this page and read the Important Facts about ADCETRIS, including BOXED WARNING.
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Tell your doctor about any side effect concerns you have

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The doctor should prescribe granulocyte colony-stimulating factor (G-CSF) along with ADCETRIS treatment right at the start. G-CSF is a medication that may help reduce the chance of neutropenia (low white blood cell count).

Don’t stop, change, or delay ADCETRIS plus AVEPC treatment unless directed by your doctor. The doctor may take additional steps to help manage side effects, including:

  • Reducing your ADCETRIS dosage, or delaying your next dose, until symptoms improve
  • Stopping ADCETRIS completely if side effects are severe or do not improve


For more information about understanding side effects, download a copy of the ADCETRIS side effects guide

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Learn more about what you can expect before starting ADCETRIS treatment.

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Find out how ADCETRIS is given
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Glossary

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AVEPC: A combination of 5 chemotherapies—combination with doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide.

ABVEPC: A combination of 6 chemotherapies—combination with doxorubicin, bleomycin, vincristine, etoposide, prednisone, and cyclophosphamide.

Event-free survival: The length of time that the patient remains free of certain complications or events.

G-CSF: Granulocyte colony-stimulating factor, a medication that can help boost white blood cell count.

Median: The middle number in a list of numbers.