Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Trial ID or NCT#
Status
NOT RECRUITING
Purpose
The purpose of this study is to compare the outcomes across the 4 different treatment groups. The investigators hope that this treatment will improve the ability to cure more patients with HL and also limit the long-term side effects from the treatment. Although eliminating radiation in cohort 4 will eliminate the risk for long-term side effects from radiation, it is also possible that with BV+AVD chemotherapy alone there may be an increased risk of the Hodgkin lymphoma coming back after initial treatment.
Official Title
A Pilot Study of Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Eligibility Criteria
- - Histologic diagnosis of classical, CD30 positive Hodgkin lymphoma confirmed at enrolling institution - FDG-avid disease by FDG-PET/CT and measurable disease of at least 1.5 cm by CT - Ann Arbor Stage I or II disease - Disease bulk defined as any lymph node mass with transverse maximal diameter > 7.0 cm OR coronal maximal diameter > 7.0 cm on CT imaging - Females of childbearing age must be on an acceptable form of birth control per institutional standards - Ages 18 and over
- - Cardiac ejection fraction ≤ 50% - Hemoglobin-adjusted diffusing capacity for carbon monoxide < 40% - ANC≤1000/μl and Platelets≤75,000/μl - Total bilirubin ≥ 2.0 mg/dl in the absence of a history of Gilbert's disease - Serum creatinine clearance of <30 mL/min as estimated by the Cockcroft-Gault Method - Known pregnancy or breast-feeding - Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - Medical illness unrelated to Hodgkin Lymphoma, which, in the opinion of the attending physician and/or MSKCC principal investigator, makes participation in this study inappropriate. - Peripheral neuropathy > grade 1 - Patients receiving chronic treatment with systemic steroids. However, patients can receive up to 10 days of steroid therapy prior to starting treatment with BV+AVD.
Investigator(s)
Contact us to find out if this trial is right for you.
Contact
Sipra Choudhury
650-736-2563
View on ClinicalTrials.gov
