Ensayos clínicos

Major Inclusion Criteria

Diagnosis/Trial Population

• Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL):
  • history of diagnosis of CLL or SLL that meets IWCLL diagnostic criteria
  • histologically confirmed diagnosis of SLL by lymph node biopsy
  • indication for treatment as defined by the IWCLL guidelines
• Patients must have both of the following:
  • relapsed or refractory disease while receiving a BTKi therapy or intolerance of such therapy
  • single-agent or combination therapy with a BTKi for at least one month must be the patient's most recent prior anticancer therapy
• ECOG performance status of 0 to 2
• Patients with a past medical history of autologous or allogeneic stem cell transplantation must exhibit full hematological recovery

Laboratory Values

• Patients must meet adequate bone marrow function and adequate hepatic and renal function

Other Inclusion Criteria

• Females of childbearing potential must use a highly effective method of contraception

Major Exclusion Criteria

Diagnosis

• Patients who have:

• Non-Hodgkin's lymphomas other than CLL/SLL
• Transformed CLL/SLL or Richter's syndrome
• Active and uncontrolled autoimmune cytopenia

Previous and Current Treatment

• Patients who have received treatment with a BTK inhibitor within 5 days prior to Day 1 dosing
• Patients who have, within 14 days prior to D1 dosing:
  • Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy, investigational anticancer therapy or other lymphoma specific therapy
  • Systemic corticosteroids in doses greater than prednisone equivalent to 20 mg/day with the exception of patients with signs of rapidly progressing disease
  • Received live vaccines with the exception of vaccination against influenza with inactivated virus or for pneumococcal diseases