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New treatment option for Chronic Lymphocytic Leukemia
Official title A Randomized Phase II Study Of Bruton Tyrosine Kinase Inhibitor With Or Without Venetoclax In Veterans With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
ClinicalTrials.gov ID: NCT06520098
What this study is testing
What is Venetoclax?
Venetoclax is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for chronic lymphocytic leukemia.
Also referred to as VENCLEXTA.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- People who have chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) are often treated with ibrutinib, acalabrutinib, or zanubrutinib. These are pills that are taken by mouth.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- CLL or SLL diagnosis
- Patients must have been diagnosed with CLL (\> 5000 B-cells per uL of peripheral blood at any point during the course of their disease) or small...
- Prior treatment
- Patients must be currently receiving CLL/SLL directed therapy with a BTKi (i.e., ibrutinib, acalabrutinib, zanubrutinib) for at least six months.
- The dose of BTKi must be stable for at least the past three months.
You likely can't join if
- Prior treatment
- Patients must not have progression of CLL/SLL on BTKi therapy prior to initiation of the study therapy.
- Patients must not have received the combination of BTKi + venetoclax previously.
- Comorbid conditions or other active diseases
- Patients must not have any history of Richter's transformation or prolymphocytic leukemia.
- If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and be on suppressive therapy, if indicated.
See the full eligibility criteria
- CLL or SLL diagnosis
- Patients must have been diagnosed with CLL (\> 5000 B-cells per uL of peripheral blood at any point during the course of their disease) or small lymphocytic lymphoma (SLL) with \<5000 B-cells per µL of blood but with...
- Prior treatment
- Patients must be currently receiving CLL/SLL directed therapy with a BTKi (i.e., ibrutinib, acalabrutinib, zanubrutinib) for at least six months.
- The dose of BTKi must be stable for at least the past three months.
- Age 18 years
- ECOG performance status 0-2
- Detectable or measurable CLL/SLL in blood or imaging during the screening period. Detectable CLL/SLL in the blood is defined either by elevation in absolute lymphocyte count or by diagnostic flow cytometry from blood...
- Low TLS risk, defined as having all lymph nodes less than 5 cm in diameter (radiographically) and absolute lymphocyte count less than 25 x 109/L in blood, within 30 days of enrollment.
- Required initial laboratory values
- Absolute Neutrophil Count (ANC) 1,000/mm3 except if due to bone marrow involvement
- Platelet Count (untransfused) 30,000/mm3 except if due to bone marrow involvement
- Calc. Creatinine Clearance 40 mL/min (by Cockcroft-Gault)
- Bilirubin 1.5 x upper limit of normal (ULN) except if due to liver involvement, hemolysis, or Gilbert's disease
- AST / ALT 2.5 x upper limit of normal (ULN) except if due to liver involvement
- Other
- Patients must be able to swallow oral medications and not have the following conditions: disease significantly affecting gastrointestinal absorption, resection of the stomach or small bowel, partial or complete bowel...
- Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase
- Prior treatment
- Patients must not have progression of CLL/SLL on BTKi therapy prior to initiation of the study therapy.
- Patients must not have received the combination of BTKi + venetoclax previously.
- Comorbid conditions or other active diseases
- Patients must not have any history of Richter's transformation or prolymphocytic leukemia.
- If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable and be on suppressive therapy, if indicated.
- Please note: IVIG can cause a false positive hepatitis B serology. If patients receiving routine IVIG have core antibody or surface antigen positivity without evidence of active viremia (negative hepatitis B DNA) they...
- If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load.
- Patients with Class III or Class IV heart failure by New York Heart Association, those with unstable angina, and those with uncontrolled arrhythmia are not eligible.
- Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy are eligible for this trial.
- Concomitant medications
- Patients must not be receiving active systemic anticoagulation with heparin or warfarin. Patients on warfarin must discontinue the drug for at least 10 days prior to registration on the study.
- Chronic concomitant treatment with strong inhibitors of CYP3A4/5 is not recommended on this study. Patients on strong CYP3A inhibitors must discontinue the drug for 14 days prior to registration on the study or discuss...
- Chronic concomitant treatment with strong CYP3A4/5 inducers is not recommended. Patients must discontinue the drug 14 days prior to registration on the study or discuss with the study principal investigator.
- Patients must not require more than 20 mg prednisone or equivalent corticosteroid daily.
- Patients must not have uncontrolled active systemic infection requiring intravenous antibiotics
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Kansas City, Missouri, United States
- Durham, North Carolina, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Kansas City, Missouri, United States; Durham, North Carolina, United States; Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.