Hematology

A Phase II Trial of Response-Adapted Therapy of Stage III-IV Hodgkin Lymphoma Using Early Interim FDG-PET Imaging

Hodgkin Lymphoma

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.

Clinicaltrials.gov ID: Yale7881847