Non Hodgkin Lymphoma Clinical Trial
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Summary
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.
Eligibility Criteria
Inclusion 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
Exclusion Criteria:
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.
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There are 9 Locations for this study
Duarte California, 91010, United States
Stanford California, 94305, United States
Basking Ridge New Jersey, 07920, United States
Middletown New Jersey, 07748, United States
Montvale New Jersey, 07645, United States
Commack New York, 11725, United States
Harrison New York, 10604, United States
New York New York, 10065, United States
Rochester New York, , United States
Uniondale New York, 11553, United States
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