Principal Investigator
Enrollment Status
Clinical Trial ID
Clinical Trial Summary
This phase III trial studies brentuximab vedotin and combination chemotherapy to see how well
they work compared to combination chemotherapy alone in treating children and young adults
with stage IIB with bulk, stage IIIB, IVA, or IVB Hodgkin lymphoma. Combinations of
biological substances in brentuximab vedotin may be able to carry cancer-killing substances
directly to Hodgkin lymphoma cells. Chemotherapy drugs, such as doxorubicin hydrochloride,
bleomycin sulfate, vincristine sulfate, etoposide, prednisone, and cyclophosphamide, 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. It is not yet known if combination
chemotherapy is more effective with or without brentuximab vedotin in treating children with
high-risk Hodgkin lymphoma.
Phase
Phase 3
Funding Agency/Sponsor
National Cooperative Group
Disease
Pediatric Cancer
Enrollment Eligibility
Inclusion Criteria:
- Patients with newly diagnosed, pathologically confirmed cHL meeting one of the
following Ann Arbor stages are eligible:
- Stage IIB with bulk
- Stage IIIB
- Stage IVA
- Stage IVB
- If study eligibility by staging is uncertain, consultation with Imaging and
Radiation Oncology Core (IROC) Rhode Island (RI) may be obtained prior to
study enrollment
- Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70
mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (performed within
14 days prior to enrollment):
- 2 to < 6 years: male 0.8 mg/dL, female 0.8 mg/dL
- 6 to < 10 years: male 1 mg/dL, female 1 mg/dL
- 10 to < 13 years: male 1.2 mg/dL, female 1.2 mg/dL
- 13 to < 16 years: male 1.5 mg/dL, female 1.4 mg/dL
- >= 16 years: male 1.7 mg/dL, female 1.4 mg/dL
- Total bilirubin =< 1.5 x upper limit of normal (ULN) for age (performed within 14 days
prior to enrollment)
- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate transaminase [AST]) or serum
glutamate pyruvate transaminase (SGPT) (alanine transaminase [ALT]) < 2.5 x upper
limit of normal (ULN) for age (performed within 14 days prior to enrollment)
- Shortening fraction of >= 27% by echocardiogram, or ejection fraction of >= 50% by
radionuclide angiogram
- Forced expiratory volume in 1 second (FEV1)/forced vital capacity (FVC) > 60% by
pulmonary function test (PFT), unless due to large mediastinal mass from Hodgkin
lymphoma (HL)
- For children who are unable to cooperate for PFTs, the criteria are: no evidence of
dyspnea at rest, no exercise intolerance, and a pulse oximetry reading of > 92% on
room air
- All patients and/or their parents or legal guardians must sign a written informed
consent
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Exclusion Criteria:
- Patients with nodular lymphocyte-predominant HL
- Patients with an immunodeficiency that existed prior to diagnosis, such as primary
immunodeficiency syndromes, organ transplant recipients and children on current
systemic immunosuppressive agents are not eligible
- Patients who are pregnant; (since fetal toxicities and teratogenic effects have been
noted for several of the study drugs, a negative pregnancy test is required for female
patients of childbearing potential)
- Lactating females who plan to breastfeed
- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation and for
30 days after the last dose of chemotherapy
- Patients known to be positive for human immunodeficiency virus (HIV) are not eligible
- Patients who have received any previous chemotherapy or radiation therapy are not
eligible
- Patients who received systemic corticosteroids within 28 days of enrollment on this
protocol, except as specified, are not eligible