Actively Recruiting
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
Led by M.D. Anderson Cancer Center · Updated on 2026-04-30
60
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
L
Loxo Oncology, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time-limited Triplet Combination of Pirtobrutinib, Venetoclax, and Obinutuzumab for Patients With Treatment-naïve Chronic Lymphocytic Leukemia (CLL) or Richter Transformation (RT)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of previously untreated CLL/SLL needing treatment or untreated/relapsed Richter transformation (RT) if previously treated for CLL
- Age 18 years or older
- ECOG performance status of 0 to 2
- Adequate liver function with specific bilirubin, ALT, and AST limits
- Adequate kidney function with creatinine clearance ≥ 50 ml/min
- Adequate blood counts: platelets ≥ 50 x10^9/L, hemoglobin ≥ 8 g/dL, neutrophils ≥ 0.75 x10^9/L
- Ability to swallow tablets and comply with outpatient treatment and monitoring
- Women of childbearing potential must have a negative pregnancy test and agree to effective contraception during and 6 months after treatment
- Men with partners of childbearing potential must agree to use effective contraception during and 6 months after treatment
You will not qualify if you...
- Major surgery within 4 weeks before starting study drugs
- Uncontrolled active systemic infection
- Known positive HIV infection
- Active hepatitis B or hepatitis C infection
- Known active cytomegalovirus infection
- Active uncontrolled autoimmune conditions needing high-dose steroids or recent therapy changes
- Significant uncontrolled heart disease or recent serious cardiovascular events
- Prolonged QT interval above 470 msec without cardiology clearance
- Pregnancy, breastfeeding, or planning pregnancy during study or within 6 months after treatment
- Use of warfarin or vitamin K antagonists
- Current treatment with strong CYP3A4 inhibitors or inducers without appropriate washout
- Current treatment with certain P-glycoprotein inhibitors without appropriate washout
- Known CNS involvement by CLL/SLL/RT
- Active second cancer unless in remission with life expectancy over 2 years, except certain skin or cervical cancers
- Prior treatment restrictions including recent therapies, transplant, or CAR-T therapy with ongoing complications
- Known allergy to study drugs or excipients
- Conditions affecting absorption of study drugs
- Live-virus vaccine within 4 weeks before starting study drugs
- History of bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Nitin Jain, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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