Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Completed · Not applicable
Conditions studied: Hodgkin Lymphoma
In brief
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.
Key facts
- Study ID
- NCT01868451
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 118
- Starts
- 2013-05-01
- Expected to finish
- 2026-06-02
- Last updated by the study team
- 2026-06-04
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- City of Hope — Duarte, California, United States
- Stanford University Medical Center — Stanford, California, United States
- Memorial Sloan Kettering Basking Ridge — Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
- Memorial Sloan Kettering Bergen — Montvale, New Jersey, United States
- Memorial Sloan Kettering Commack — Commack, New York, United States
- Memorial Sloan Kettering Westchester — Harrison, New York, United States
- Memorial Sloan Kettering Cancer Center — New York, New York, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Memorial Sloan Kettering Nassau — Uniondale, New York, United States
Full record on ClinicalTrials.gov
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