M.D. Anderson Cancer Center
To learn if the combination of pirtobrutinib (also called LOXO-305), venetoclax, and obinutuzumab is safe and effective when given to patients with chronic lymphocytic leukemia (CLL) or Richter transformation (RT) who have not previously received treatment.
Primary Objective: 1\. Estimate the therapeutic activity (undetectable measurable residual disease \[U-MRD\] rate) of combined pirtobrutinib, venetoclax, and obinutuzumab in patients with previously untreated CLL/SLL (cohort 1) by undetectable measurable residual disease (U-MRD) rate and Richter transformation (cohort 2) by overall response rate (ORR) (defined as CMR//PMR). Secondary Objectives: 1. To estimate the therapeutic activity of combination therapy by determining: 1. Combined response rate (defined as CR/CRi/PR) as assessed by the investigator for cohort 1 (CLL/SLL) 2. Progr…
Inclusion Criteria: 1. Patients with a diagnosis of previously untreated CLL/SLL meeting iwCLL 2018 indication for treatment (cohort 1) or with a diagnosis of previously untreated or relapsed/refractory RT arising from CLL (cohort 2). Previously untreated patients with RT must have received prior therapy for CLL. 2. At least 18 years of age 3. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2 4. Adequate hepatic function 1. Total bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease or documented disease involvement of liver (In pts…
Given by PO
Given by (IV) vein
Given by PO
Given by PO
Given by PO
Arctuva estimate
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