Actively Recruiting
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
Led by M.D. Anderson Cancer Center · Updated on 2025-11-21
90
Participants Needed
1
Research Sites
519 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a single center, open-label, phase II study of venetoclax (ABT-199) added to ibrutinib or acalabrutinib in patients with high-risk CLL who have received at least 12 months of ibrutinib or acalabrutinib monotherapy. The study will estimate the therapeutic efficacy of venetoclax consolidation in patients who have detectable CLL after receiving ibrutinib or acalabrutinib for at least 12 months and who have high risk CLL.
CONDITIONS
Official Title
Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of chronic lymphocytic leukemia (CLL) with high-risk features such as del(17p), TP53 mutation, or complex metaphase karyotype
- At least 12 months of prior treatment with ibrutinib or acalabrutinib
- Measurable CLL by lymphocyte count, lymph nodes, bone marrow involvement, or detectable minimal residual disease
- Age 18 years or older
- ECOG Performance Status of 2 or less
- Adequate kidney function with serum creatinine clearance of at least 50 ml/min
- Adequate liver function with bilirubin and liver enzymes within specified limits
- Adequate bone marrow function with minimum platelet count, ANC, and hemoglobin levels
- INR less than 1.5
- Adequate heart function without uncontrolled arrhythmia and with LVEF of at least 35%
- Ability to provide informed consent and follow study requirements
- Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and 30 days after treatment
- Men with partners of childbearing potential must agree to use effective contraception during and 30 days after treatment
- Written informed consent provided
You will not qualify if you...
- Richter transformation
- Active cancers requiring treatment other than CLL, except certain treated localized cancers
- Major surgery, radiotherapy, chemotherapy, biologic, immunotherapy, or experimental therapy within 3 weeks prior to study start
- Grade 3 or 4 bleeding within the past 3 weeks
- Uncontrolled active infections
- Pregnancy or breastfeeding
- Known HIV infection
- Active hepatitis B or C infection
- Active autoimmune conditions requiring high-dose steroids
- Recent use of investigational therapies for CLL
- Concurrent use of warfarin
- Recent use of strong CYP3A inhibitors or inducers
- Consumption of grapefruit, Seville oranges, or star fruit within 7 days prior to treatment
- Prior treatment with venetoclax or other Bcl-2 inhibitors
- Conditions preventing oral medication intake such as malabsorption syndrome
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
A
Alessandra Ferrajoli, 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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