Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With… (NCT05536349) | Clinical Trial Compass
RecruitingPhase 2
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
United States60 participantsStarted 2022-12-20
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. At least 18 years of age
✓. Eastern Cooperative Oncology Group (ECOG) Performance status of 0-2
✓. Adequate hepatic function
✓. 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 with elevated total bilirubin due to increased indirect bilirubin, pts with direct bilirubin ≤1.5 x ULN are eligible)
✓. ALT and AST ≤3.0 x ULN, or ≤5.0 x ULN if documented disease involvement of liver
✓. Adequate renal function
✓. Adequate hematologic function a. Platelet count ≥50 x109/L and hemoglobin ≥ 8 g/dL (≥ 80 g/L). Platelet and hemoglobin requirements are independent of transfusions within 7 days of screening assessment and first dose of study drugs.
Exclusion criteria
✕. Major surgery within 4 weeks prior to the first dose of study drugs
✕. Uncontrolled active systemic infection
✕. Known positive serology for human immunodeficiency virus (HIV)
What they're measuring
1
The severity of the adverse events (AEs) will be graded according to the U.S. Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0.
Timeframe: through study completion an average of 1 year.
. Active hepatitis B infection (defined as the presence of detectable HBV DNA, HBe antigen or HBs antigen). Patients with serologic evidence of prior vaccination (HBsAg negative, anti-HBs antibody positive, anti-HBc antibody negative) are eligible. Patients who are HBsAg negative/HBsAb positive but HBcAb positive are eligible, provided HBV DNA is negative and they are willing to take appropriate anti-viral prophylaxis
✕. Active hepatitis C infection (defined as detectable hepatitis C RNA in plasma by PCR)
✕. Known active cytomegalovirus (CMV) infection. Unknown or negative status are eligible
✕. Active, uncontrolled autoimmune phenomenon (autoimmune hemolytic anemia or immune thrombocytopenia) requiring steroid therapy with \> 20 mg daily of prednisone or equivalent or for which new therapy was introduced or existing therapy was escalated within the 4 weeks prior to study enrollment to maintain adequate blood counts
✕. Clinically significant, uncontrolled cardiovascular disease (≥3 NYHA heart failure, uncontrolled or symptomatic arrythmias), or myocardial infarction within 6 months, or stroke within 6 months, or intracranial bleeding within 6 months prior to start of study drugs