Clinical Trial 18361

Cancer Type: Malignant Hematology
Interventions:Adcetris (Brentuximab vedotin); Adriamycin (doxorubicin); Brentuximab vedotin; DTIC (Dacarbazine); Dacarbazine; SGN-35 (Brentuximab vedotin)

Study Type: Treatment
Phase of Study: Phase II


    Study Title

    Brentuximab Vedotin Plus AD in Non-bulky Limited Stage Hodgkin Lymphoma


    The purpose of this study is to see whether brentuximab in combination with Adriamycin and Dacarbazine (AD) is effective in treating Hodgkin Lymphoma.


    Primary Objective: To investigate the clinical activity of Brentuximab with AD in untreated non-bulky stage I and II Classical Hodgkin Lymphoma (cHL). Secondary Objective: To describe the safety and tolerability of Brentuximab combined with AD in previously untreated non-bulky limited stage cHL.

    Inclusion Criteria


  • Previously untreated stage IA, IB, or IIA classical Hodgkin Lymphoma
  • Non-bulky disease defined as less than 10 cm in maximal diameter
  • Measurable disease ≥1.5 cm
  • Age ≥18
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Participants must have initial organ and marrow function defined as: Absolute neutrophil count (ANC) ≥ 1,000/mcL; Platelets ≥100,000/mcL; Total bilirubin ≤ 2, unless due to Gilbert's disease; AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal (ULN); Creatinine clearance ≥ 30 mL/min
  • Left ventricular ejection fraction (LVEF) by echocardiogram or multigated acquisition (MUGA) within institutional normal limits
  • Participant must be willing to use two effective forms of birth control during protocol therapy. Men and women must continue using two effective forms of birth control for 6 months following treatment.
  • Ability to understand and the willingness to sign a written informed consent document

  • Exclusion Criteria


  • Participants who have had prior classical Hodgkin lymphoma (cHL) directed chemotherapy or radiotherapy
  • Participants may not be receiving any other investigational agents
  • Participants with known central nervous system (CNS) involvement of lymphoma
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to Adriamycin, Dacarbazine, or brentuximab
  • Pre-existing grade 2 or greater neuropathy
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Women who are pregnant or nursing
  • Participants with a history of a different malignancy are ineligible unless they have been disease free for 1 year and considered at low risk for relapse, except for: cervical cancer in situ, ductal carcinoma in situ, localized prostate cancer with no detectable disease by imaging studies, and non-melanoma cancers of the skin, which are eligible at any time.
  • Known HIV positivity