Protocol Title: A Phase I, Open-label, Dose Escalation Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of ONO-7018 in Patients with Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) or Chronic Lymphocytic Leukemia (CLL)

Sponsor: Ono Pharmaceuticals

Protocol Number: ONO-7018-01

Key Criteria

  • B-Cell NHL, T-Cell NHL, or CLL/SLL- Relapsed/Refractory patients who have no available therapeutic options known to provide clinical benefit
    • B-Cell NHL
      • DLBCL, FL, MZL, MCL, or WM
    • T-Cell NHL
      • Peripheral Tcell Lymphoma
    • CLL/SLL
      • CLL; Clonal B cells greater than or equal to 5,000 cells/ microliter in the peripheral blood
      • SLL; Lymphadenopathy with histopatholigical evaluation consistent with SLL, absence of cytopenia caused by clonal marrow infiltrate, and < 5,000 cells/ microliter in the peripheral blood

Talking Points

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