Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi
Condition: Leukemia, Lymphocytic, Chronic, B-Cell; Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Intervention: Tafasitamab; Idelalisib; Venetoclax
Intervention description: tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion; idelalisib dose: 150 mg twice daily orally; venetoclax dose: 400 mg once daily orally
Intervention MeSH terms: Venetoclax; Idelalisib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: CD19; MOR208; MOR00208; CLL; SLL; COSMOS; tafasitamab

Summary:

      This is a two-cohort, multicenter, open-label study of tafasitamab (MOR208) combined with
      idelalisib or venetoclax in adult patients with R/R CLL or R/R SLL pretreated with a BTK
      inhibitor (e.g., ibrutinib) as single agent or as part of combination therapy. Patients
      completing the study treatment are invited to participate in an optional biomarker sub-study.
    

Eligibility criteria:

        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