Trial Search Results

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

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Memorial Sloan Kettering Cancer Center

Collaborator: Stanford University

Stanford Investigator(s):

Intervention(s):

  • Drug: Brentuximab vedotin (SGN-35)
  • Drug: Doxorubicin HCL
  • Drug: Vinblastine Sulfate
  • Drug: Dacarbazine
  • Radiation: Involved-Site Radiation Therapy (ISRT)
  • Procedure: Interim PET
  • Radiation: consolidation volume RT (CVRT)

Phase:

N/A

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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sipra Choudhury
650-736-2563
Recruiting