Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma

Last updated: November 17, 2025
Sponsor: St. Jude Children's Research Hospital
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

Lymphoma

Treatment

prednisone

radiation therapy

cyclophosphamide

Clinical Study ID

NCT01920932
HLHR13
NCI-2013-01123
  • Ages < 18
  • All Genders

Study Summary

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroidtherapy - maximum of 7 days - because of cardiopulmonary decompensation or spinalcord compression will be eligible for protocol enrollment).

  • Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday).

  • Ann Arbor stage IIB, IIIB, IVA, or IVB.

  • Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinineadjusted for age and gender.

  • Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5x ULN for age).

  • Female participant who is post-menarchal must have a negative urine or serumpregnancy test.

  • Female or male participant of reproductive potential must agree to use an effectivecontraceptive method throughout duration of study treatment.

Exclusion

Exclusion Criteria:

  • CD30 negative HL.

  • Has received prior therapy for Hodgkin lymphoma, except as noted above.

  • Inadequate organ function as described above.

  • Inability or unwillingness of research participant or legal guardian /representative to give written informed consent.

Study Design

Total Participants: 77
Treatment Group(s): 9
Primary Treatment: prednisone
Phase: 2
Study Start date:
August 12, 2013
Estimated Completion Date:
May 31, 2028

Study Description

PRIMARY OBJECTIVES:

  • To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL).

  • To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study.

SECONDARY OBJECTIVES:

  • To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA.

  • To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL.

  • To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

  • To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure).

  • To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study.

OUTLINE:

AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Connect with a study center

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto, California 94304
    United States

    Site Not Available

  • Lucile Packard Children's Hospital Stanford University

    Palo Alto 5380748, California 5332921 94304
    United States

    Site Not Available

  • St. Jude Midwest Affiliate

    Peoria, Illinois 61637
    United States

    Site Not Available

  • St. Jude Midwest Affiliate

    Peoria 4905687, Illinois 4896861 61637
    United States

    Site Not Available

  • Maine Children's Cancer Program (MCCP)

    Scarborough, Maine 04704
    United States

    Site Not Available

  • Maine Children's Cancer Program (MCCP)

    Scarborough 4977882, Maine 4971068 04704
    United States

    Site Not Available

  • Dana-Farber Harvard Cancer Center

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Dana-Farber Harvard Cancer Center

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Massachusetts General Hospital Cancer Center

    Boston 4930956, Massachusetts 6254926 02114
    United States

    Site Not Available

  • St. Jude Children's Research Hospital

    Memphis, Tennessee 38105
    United States

    Site Not Available

  • St. Jude Children's Research Hospital

    Memphis 4641239, Tennessee 4662168 38105
    United States

    Site Not Available

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