A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging
What is the purpose of this trial?
The co-primary objectives are:
- To estimate the 2-year progression-free survival (PFS) in HIV-negative patients with advanced stage Hodgkin Lymphoma (HL) treated with response-adapted therapy based on FDG-PET imaging after 2 cycles of adriamycin, bleomycin,vinblastine, and dacarbazine (ABVD).
- To estimate the 2-year PFS in the subset of HIV-negative patients with advanced stage HL who are PET-positive after 2 cycles of ABVD and are subsequently treated with escalated dose BEACOPP.
Secondary objectives include:
- To estimate the 2-year overall survival (OS) for HIV-negative patients treated with response- adapted therapy.
- To estimate the response rate (complete and partial) for HIV-negative patients treated with response- adapted therapy.
- To evaluate the toxicity of this response-adapted regimen.
- To document the feasibility of centralized, real-time review of FDG-PET imaging for U.S. cooperative group studies.
- To prospectively evaluate the overall response rate, complete response rate, PFS, and OS of a cohort of HIV-positive patients with HL treated with response-adapted therapy.The use of cycle-2 PET scanning in HIV infection will be done to provide preliminary data for this strategy in HIV-infected patients.
- To prospectively identify serum and tissue biomarkers associated with progression-free and overall survival of patients with HL treated with response-adapted therapy. Biologic features meriting specific investigation include the degree of tumor cell infiltration with Tregulatory cells, the FOXP3/Granzyme B ratio, and the expression of MAL or Bcl-2 in biopsy samples, and TARC levels in serum specimens.
- To prospectively evaluate HIV viral load and CD4 cells in the cohort of HIV-positive patients with HL treated with response-adapted therapy.
- 18 Years and older
- Southwest Oncology Group
- June 2012
- Last Updated:
- Study HIC#:
Clinicaltrials.gov ID: Yale7881847