Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients Wi… (NCT03233347) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Doxorubicin, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients With Stage I-II Hodgkin Lymphoma
United States82 participantsStarted 2017-10-13
Plain-language summary
This phase II trial evaluates how well AVD (doxorubicin, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and/or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.
Who can participate
Age range
18 Years – 60 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:
* Measurable disease (\>= 1.5 cm) as assessed by 2 dimensional measurement by computed tomography (CT)
* Previously untreated stage I or II non-bulky (defined as a mass measuring \< 10 cm in the longest dimension by CT) classical Hodgkin lymphoma
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2
* Life expectancy \>= 3 months
* Documented negative serologic testing for human immunodeficiency virus (HIV), hepatitis B (unless serologically positive due to prior vaccination), and hepatitis C =\< 1 year prior to registration
* White blood cell \>= 2,000 /mm\^3 without transfusion support \> 7 days prior to registration
* Hemoglobin \>= 8.5 g/dL without transfusion support \> 7 days prior to registration
* Absolute neutrophil count (ANC) \>= 1,000 cells/mm\^3 without transfusion support \> 7 days prior to registration
* Platelet count \>= 75,000/mm\^3 without transfusion support \> 7 days prior to registration
* Alanine and aspartate aminotransferase (ALT/AST) =\< 2.5 x upper limit of normal (ULN) obtained =\< 14 days prior to registration
* Total serum bilirubin =\< 1.5 x ULN (if documented Gilberts syndrome =\< 3 x ULN) obtained =\< 14 days prior to registration
* Serum creatinine =\< 1.5 x ULN or measured calculated creatinine clearance \>= 40 ml/min for subject with creatinine levels \> 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =\< 14 days prior to registration
* Negative serum pregnancy test (minimum sensitivity …
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
Progression free survival
Timeframe: From registration, where progression is by computed tomography (CT)-based or positron emission tomography (PET)-CT based criteria, assessed at 3 years
Trial details
NCT IDNCT03233347
SponsorAcademic and Community Cancer Research United