Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: City of Hope Medical Center; Seagen Inc.; Seattle Genetics, Inc.; Stanford University; University of Rochester
• Treatments: Antibodies, Monoclonal; Brentuximab Vedotin; Dacarbazine; Doxorubicin; Liposomal doxorubicin; Vinblastine

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.