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
Lauren Maeda

Clinical Associate Professor, Medicine - Oncology

Ranjana Advani
Ranjana Advani

Saul A. Rosenberg, MD, Professor of Lymphoma

Neel K. Gupta
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

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