Status:
ACTIVE_NOT_RECRUITING
Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
Seagen Inc.
University of Rochester
Conditions:
Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2026
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT01868451
Start Date
May 1 2013
End Date
May 1 2026
Last Update
July 9 2025
Active Locations (10)
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1
City of Hope
Duarte, California, United States, 91010
2
Stanford University Medical Center
Stanford, California, United States, 94305-5408
3
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, United States, 07920
4
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748