Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage… (NCT02166463) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
United States600 participantsStarted 2015-03-19
Plain-language 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.
Who can participate
Age range2 Years – 22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 (…
What they're measuring
1
Event Free Survival (EFS), Where Events Include Disease Progression or Relapse, Second Malignancy, or Death
Timeframe: Up to 48 months after the last enrollment