Induction Chemo w/ABVD Followed by Brentuximab Vedotin Consolidation in Newly Diagnosed, Non-Bulky Stage I/II Hodgkin Lymphoma
Condition: Hodgkin Lymphoma, Adult
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional

Summary: 
      The standard chemotherapy for Hodgkin lymphoma is called ABVD which is a combination of 4
      chemotherapy drugs (doxorubicin, bleomycin, vinblastine, and dacarbazine). The number of
      cycles of ABVD chemotherapy Hodgkin lymphoma patients receive is about 4-6 cycles. In
      addition to the ABVD chemotherapy, patients with Hodgkin lymphoma will routinely receive
      radiation therapy. The use of chemotherapy and radiation may cause long term treatment
      related side effects such as heart problems and other cancers. Researchers are trying to find
      if combining ABVD chemotherapy with new drugs and reducing the number of ABVD chemotherapy
      cycles given is just as effective as the standard Hodgkin treatment.

      Brentuximab vedotin is approved by the United States Food and Drug administration (FDA) for
      the treatment of Hodgkin lymphoma that has come back (relapsed). For this research study, the
      use of brentuximab vedotin in newly diagnosed Hodgkin lymphoma is considered investigational.
      Brentuximab vedotin is an antibody that also has a chemotherapy drug attached to it.
      Antibodies are proteins that are part of your immune system. They can stick to and attack
      specific targets on cells. The antibody part of the brentuximab vedotin sticks to a target
      called cluster of differentiation antigen 30 (CD30). CD30 is an important molecule on some
      cancer cells and some normal cells of the immune system.

      The purpose of this research study is to see the effects of treatment with fewer cycles of
      the combination chemotherapy, ABVD, followed by the study drug brentuximab vedotin has on
      study participants and Hodgkins lymphoma.
    

Detailed description: 
      This study is designed as a single arm pilot feasibility trial using an induction of 2-6
      cycles of ABVD (doxorubicin, bleomycin, vinblastine, and dacarbazine) chemotherapy followed
      by 6 cycles of brentuximab vedotin (SGN-35) consolidation for previously untreated patients
      with stage I and II non-bulky Hodgkin Lymphoma (HL).

      Feasibility will be determined by the percentage of patients who have no clinical evidence of
      HL, and achieve positron emission tomograph (PET) negative disease post brentuximab
      consolidation. We anticipate approximately 40 patients will be eligible across participating
      centers (including UNC, Mayo Clinic, and the UNC Cancer Network (UNCCN)) over a 2 year
      period. A future phase II study evaluating progression free survival (PFS) after ABVD
      followed by brentuximab vedotin will be considered feasible if ≥ 13 of 15 patients enrolled
      in this pilot trial become PET negative after brentuximab vedotin consolidation.
    

Intervention name(s): Brentuximab vedotin; ABVD
Intervention type(s): Drug; Drug
Intervention description(s): IV, 1.8mg/kg, every 3 weeks for 6 cycles.; Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
Other intervention name(s): SGN-35; Adcetris
Intervention MeSH terms: Brentuximab Vedotin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hodgkin's lymphoma; Hodgkin lymphoma