Study of Mogamulizumab With DA-EPOCH or CHOEP in Patients With Aggressive T-cell Lymphoma

Cannot have received: systemic anti-cancer therapy

Exception: ≤ 3 weeks prior to first dose of study treatment; patients with rapidly progressive malignant disease may be enrolled prior to this period after discussion with the sponsor investigator

Has received prior systemic anti-cancer therapy including investigational agents ≤ 3 weeks prior to first dose of study treatment on Cycle 1, Day 1.

Cannot have received: radiotherapy

Exception: within 2 weeks of start of study treatment; 1-week washout permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease

Has received radiotherapy within 2 weeks of start of study treatment. A 1-week washout is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.

Cannot have received: immunomodulatory drug (methotrexate, azathioprine, iv immunoglobulin, cyclophosphamide, cyclosporine, mycophenolate, infliximab, etanercept, leflunomide, adalimumab, lenalidomide, abatacept, rituximab, anakinra, interferon-β, IL-2, natalizumab)

Exception: for concomitant or intercurrent conditions other than T-cell lymphoma or within 4 weeks of treatment; concurrent use of topical steroids or therapies for CTCL is allowed

Patients on any immunomodulatory drug for concomitant or intercurrent conditions other than T-cell lymphoma or who have received any of these agents within 4 weeks of treatment, including but not limited to the following, will be excluded: low dose or oral methotrexate; azathioprine; iv immunoglobulin; low dose or oral cyclophosphamide; cyclosporine; mycophenolate; infliximab; etanercept; leflunomide; adalimumab; lenalidomide; abatacept; rituximab; anakinra; interferon-β IL-2 and natalizumab. Concurrent use of topical steroids or therapies for CTCL is allowed as indicated in the protocol.

Cannot have received: live vaccine (measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid vaccine, intranasal influenza vaccines (e.g., FluMist®))

Exception: within 30 days prior to the first dose of study drug

Has received a live vaccine within 30 days prior to the first dose of study drug.

Cannot have received: allogeneic stem cell transplant

Exception: within last 2 years or active graft vs. host disease (GVHD)

Prior allogeneic stem cell transplant within last 2 years or active graft vs. host disease (GVHD).