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Brentuximab Vedotin Combined With AVD Chemotherapy in Patients With Newly Diagnosed Early Stage, Unfavorable Risk Hodgkin Lymphoma
Not Recruiting
Trial ID: NCT01868451
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
Stanford Investigator(s)
Lauren Maeda
Clinical Associate Professor, Medicine - Oncology
Ranjana Advani
Saul A. Rosenberg, MD, Professor of Lymphoma
Neel K. Gupta
Clinical Assistant Professor, Medicine - Oncology Clinical Assistant Professor, Medicine - Hematology
Eligibility
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.
Intervention(s):
drug: Brentuximab vedotin (SGN-35)
drug: Doxorubicin HCL
drug: Vinblastine Sulfate
radiation: Involved-Site Radiation Therapy (ISRT)
procedure: Interim PET
drug: Dacarbazine
radiation: consolidation volume RT (CVRT)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Sipra Choudhury
650-736-2563