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 range18 Years – 60 Years
SexALL
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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 …
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