Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi

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