Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

One-Year combo pill strategy may boost CLL remission rates

NCT ID NCT06520098

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at 100 people with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who are already taking a BTKi pill (like ibrutinib). Half will keep taking the BTKi alone, while the other half will add a second pill called venetoclax for one year. After that year, both pills are stopped and participants are closely watched. The goal is to see if the combination leads to more complete remissions and less fatigue.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Chronic lymphocytic leukemia are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    4 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Durham VA Medical Center, Durham, NC

    RECRUITING

    Durham, North Carolina, 27705-3875, United States

    Contact Email: •••••@•••••

  • Kansas City VA Medical Center, Kansas City, MO

    RECRUITING

    Kansas City, Missouri, 64128-2226, United States

  • San Francisco VA Medical Center, San Francisco, CA

    RECRUITING

    San Francisco, California, 94121-1563, United States

  • VA Puget Sound Health Care System Seattle Division, Seattle, WA

    RECRUITING

    Seattle, Washington, 98108-1532, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.