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 States, Canada, Puerto Rico600 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 range
2 Years – 22 Years
Sex
ALL
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 (…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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