Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Young… (NCT01920932) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma
United States77 participantsStarted 2013-08-12
Plain-language 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.
Who can participate
Age range
18 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:
* Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord 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 creatinine adjusted for age and gender.
* Adequate hepatic function (total bilirubin \< 1.5 x ULN for age, and SGOT/SGPT \< 2.5 x ULN for age).
* Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
* Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.
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.
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
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
2
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control
Timeframe: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
3
Complete Response Rate Estimate for All Evaluable Participants
Timeframe: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
4
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2).
Timeframe: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)