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RecruitingPhase 2

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)

Benefit of Venetoclax Addition ("Benefit VA") in Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year
  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "These are pills that are taken by mouth."
  • "This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi."
  • "Another treatment for CLL/SLL is a different pill called venetoclax."
  • "The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year."
  • "After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored."
  • "This type of pill is called a "Bruton Tyrosine Kinase Inhibitor" or BTKi."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for veterans with CLL or SLL, two types of blood cancer, who already take a BTKi cancer pill. It compares staying on that pill alone while it works with adding venetoclax for one year. In the added-drug group, both pills are then stopped, and patients are watched closely.

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. This type of pill is called "Bruton Tyrosine Kinase Inhibitor" or BTKi. Another treatment for CLL/SLL is a different pill called venetoclax. The purpose of this study is to compare continuing the current treatment with BTKi alone, as long as it is working, to another arm of treatment which adds venetoclax to the current treatment (BTKi), for one year. After one year, both pills in this arm of treatment would be stopped and the participants will be closely monitored.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a confirmed diagnosis of CLL or SLL, with cancer still found in blood tests or scans.
  • Have taken ibrutinib, acalabrutinib, or zanubrutinib for at least 6 months, with the same dose for at least 3 months.
  • Meet the study's age requirement, listed as 18 years.
  • Be able to care for yourself and be up and about for at least half the day.
  • Have a low risk of problems from cancer cells breaking down quickly: all lymph nodes under 5 cm and a blood lymphocyte count below the study limit.
  • Meet blood cell, kidney, and liver test requirements. Some exceptions apply if the cancer or certain other conditions affect the results.
  • Be able to swallow pills, with no major problem absorbing them, no stomach or small bowel removal, and no blocked bowel.
  • Be able to take one of the required drugs that lowers uric acid: a xanthine oxidase inhibitor or rasburicase.

Who can't join

  • CLL or SLL has worsened while taking a BTKi, or you have taken a BTKi together with venetoclax before.
  • A history of Richter's transformation, when CLL or SLL changes into a faster-growing cancer, or prolymphocytic leukemia, another blood cancer.
  • Hepatitis B that is detectable in the blood or not controlled as required. Past hepatitis C must be treated and undetectable. A false-positive hepatitis B test from IVIG does not always rule you out.
  • Severe heart failure, unstable chest pain from heart disease, or an uncontrolled uneven heartbeat.
  • Taking heparin or warfarin to prevent blood clots. Warfarin must be stopped at least 10 days before signing up.
  • Taking certain medicines that strongly change how the body handles study drugs. These must be stopped 14 days before signing up or discussed with the study leader.
  • Needing more than 20 mg of prednisone, or an equal dose of another steroid, each day.
  • An uncontrolled infection affecting the body that needs antibiotics through a vein.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion 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 disease-associated lymphadenopathy by 2018 IWCLL criteria. * 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 demonstrating presence of CLL cells. * 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 obstruction. * Patients must be able to receive either a xanthine oxidase inhibitor or rasburicase Exclusion Criteria: * 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 may still participate in the study, must have hepatitis serologies and hepatitis B DNA monitored periodically by the treating physician. * 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 with the study principal investigator. * 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

Study sites (4)

CA

MO

NC

WA