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Venetoclax with Ibrutinib or Acalabrutinib for High-Risk CLL

This study is for people with high-risk chronic lymphocytic leukemia (CLL), a type of cancer that affects white blood cells. You may be eligible if you have specific genetic changes like del(17p) or a mutated TP53 gene, and have already been taking ibrutinib or acalabrutinib for at least 12 months. The study is testing if adding venetoclax to your current treatment can help reduce the amount of CLL in your bone marrow. Researchers will measure this by looking for "MRD-negativity" (minimal residual disease negativity), meaning very few or no cancer cells are detected, after about one year of combination therapy. This is an open-label study, meaning you and your doctors will know which drugs you are receiving, and it aims to enroll 90 participants.

Study design
This is an open-label, single-center study that will enroll 90 participants. It is testing venetoclax in combination with either ibrutinib or acalabrutinib.
What's involved
You would receive venetoclax orally once daily, along with either ibrutinib or acalabrutinib. The primary goal is measured after 12 cycles of combination therapy, with each cycle lasting 4 weeks.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured after 12 cycles of combination therapy, which averages about 1 year. Other outcomes are measured after 6, 12, 18, and 24 cycles.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03128879

Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLL

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~59 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:IbrutinibVenetoclaxAcalabrutinib

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The primary endpoint will be the rate of MRD-negativity in the bone marrow, using an assay method with at least 0.01% sensitivity after 12 cycles of combination therapy. One cycle is 4 weeks of treatment.
Measured over through study completion, an average of 1 year

Conditions

Chronic Lymphocytic Leukemia

Explore related trials

Chronic Lymphocytic Leukemia17pKaryotypeTP53 Gene

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Alessandra Ferrajoli, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Absolute monoclonal lymphocyte count \> 4000/L; OR
Measurable lymph nodes with at least one node \>1.5 cm in diameter on CT; OR
Bone marrow with \>/= 30% lymphocytes on aspirate differential OR
Detectable CLL cells using a standardized flow cytometry assay for minimal residual disease 3. Age 18 years or older. 4. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2. 5. Patients must have adequate renal and hepatic function:
Serum bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN for patients with Gilbert's disease.
Serum creatinine clearance of 50ml/min (calculated or measured).
ALT and AST ≤3.0 x ULN, unless clearly due to disease involvement. 6. Adequate bone marrow function:
Platelet count of greater than 50,000/µl, with no platelet transfusion in prior 2 weeks.
ANC ≥1000/µl in the absence of growth factor support unless due to compromised bone marrow production from CLL, indicated by 80% CLL in marrow.
Hemoglobin ≥8mg/dL. 7. INR \<1.5. 8. Adequate cardiac function, as assessed by:
Absence of uncontrolled cardiac arrhythmia.
Echocardiogram demonstrating LVEF ≥35%.
NYHA functional class ≤2. 9. Ability to provide informed consent and adhere to the required follow-up. 10. Women of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (β-hCG) pregnancy test result within 7 days prior to the first dose of study drugs and must agree to use use both a highly effective method of birth control (eg, implants, injectables, combined oral contraceptives, some intrauterine devices \[IUDs\], complete abstinence , or sterilized partner) and a barrier method (eg., condoms, vaginal ring, sponge, etc) during the period of therapy and for 30 days after the last dose of study drug. Women of non-childbearing potential are those who are postmenopausal (defined as absence of menses for ≥1 year) or who have had a bilateral tubal ligation or hysterectomy. Men who have partners of childbearing potential must agree to use effective contraception, defined above, during the study and for 30 days following the last dose of study drug. 11. Patients or their legally authorized representative must provide written informed consent.

What this trial measures

  • The primary endpoint will be the rate of MRD-negativity in the bone marrow, using an assay method with at least 0.01% sensitivity after 12 cycles of combination therapy. One cycle is 4 weeks of treatment.through study completion, an average of 1 year

    One cycle is 4 weeks of treatment. (each cycle 28 days)