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

• Status: Active, not recruiting
• Trial end date: 2022-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MorphoSys AG
• Treatments: Idelalisib; Venetoclax

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