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Can a drug break improve CLL treatment for frail patients?

NCT ID NCT04963946

Disease control Sponsor: French Innovative Leukemia Organisation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 whether older, frail patients with untreated chronic lymphocytic leukemia (CLL) can safely stop taking the targeted drug acalabrutinib after 18 months and then restart it if their disease comes back. The goal is to reduce long-term side effects and the risk of drug resistance. About 160 patients aged 70 and older with other health issues will be followed for one year after stopping treatment to see how well they do without the drug.

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 160 people

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

Started

Oct 2021

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

70 years and older

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: * Age \> 70 years or older * Eastern Cooperative Oncology Group (ECOG) performance status \< 2 * Previously untreated CLL or Small Lymphocytic Lymphoma (SLL) * CLL or SLL requiring treatment according to the iwCLL 2018 criteria2 * Total Cumulative Illness Rating Scale (CIRS) score \> 6 or 30 \< CrCl \< 69 mL/min * Both patients with or without TP53 disruption 17p deletion and/or TP53 mutations) can be included * Patients can be included whatever their IGHV mutational status * Patients with therapy-controlled cardiovascular comorbidities and/or anticoagulation (novel oral anticoagulant alone, aspirin alone, heparin alone) can be included (patients treated by vitamin K antagonist or dual anti-platelet therapy cannot be included) * Life expectancy \> 6 months * Adequate hematology values: absolute neutrophil count ≥ 0.75 x 109/L, platelet count ≥ 50 x 109/L. * Adequate liver function as indicated by a total bilirubin \<1.5, aspartate transaminase and alanine transaminase ≤3 the institutional upper limits of normal values, unless directly attributable to CLL * Signed (or their legally-acceptable representatives must sign) an informed consent document indicating that they understand the purpose of and procedures required for the study, including specify biology analysis, and are willing to participate in the study. Exclusion Criteria: * Known HIV seropositivity * Evidence of other clinically significant uncontrolled condition(s) including, but not limited to: * Uncontrolled and/or active systemic infection (viral, bacterial or fungal) * Known history of human immunodeficiency virus, serologic status reflecting active hepatitis B virus or hepatitis C virus infection, any uncontrolled active systemic infection along with subjects who are on ongoing anti-infective treatment and subjects who have received vaccination with a live attenuated vaccine within 4 weeks before the first dose of study treatment 1. Subjects who are hepatitis B core antibody (anti-HBc) positive and who are hepatitis B surface antibody (anti-HBs) negative will need to have a negative hepatitis B virus Polymerase Chain Reaction (PCR) result before enrollment. Those who are hepatitis B surface antigen (HBsAg) positive or hepatitis B virus PCR positive will be excluded. 2. Subjects who are hepatitis C virus antibody positive will need to have a negative hepatitis C virus PCR result before enrollment. Those who are hepatitis C virus PCR positive will be excluded * Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive Direct Antiglobulin Testing (DAT) is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP). * Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura. * Patients treated by vitamin K antagonist or dual anti-platelet therapy * History of bleeding diathesis (e.g. hemophilia or von Willebrand disease) * History of confirmed progressive multifocal leukoencephalopathy (PML). * Concurrent severe diseases which exclude the administration of therapy : * heart insufficiency New York Heart Association (NYHA) grade III/IV, Left Ventricular Ejection Fraction (LEVF) \< 50% and or Recirculation Fraction (RF) \< 30%, myocardial infarction within the past 6 months prior to study * Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of Screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional (Subjects with controlled, asymptomatic atrial fibrillation are allowed to enroll on study) * severe chronic obstructive lung disease with hypoxemia * history of stroke or intra-cranial hemorrhage within the last 6 months * severe diabetes mellitus * uncontrolled hypertension * impaired renal function with creatinine clearance \< 30 ml/min according the formula of Cockcroft and Gault * Patient who requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study. * Disease significantly affecting gastrointestinal function (malabsorption syndrome, stomach or small bowel resection) * Evidence for Richter syndrome * Treatment with any of the following within 7 days prior to the first dose of study drug: steroid therapy for anti-neoplastic intent. * A significant history of renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, or hepatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in this study or interpretation of study outcomes * Major surgery within 30 days prior to the first dose of study treatment. * History of prior other malignancy that could affect compliance with the protocol or interpretation of results, with the exception of the following: * curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study. * other cancers not specified above that have been curatively treated by surgery and/or radiation therapy from which patient is disease-free for ≥ 5 years without further treatment * Adult under law-control * Fertile male patients who cannot or do not wish to use an effective method of contraception, during and for 12 months after the final treatment used for the purposes of the study * No affiliation to social security

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia

As listed by the trial registrant

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

Untreated chronic lymphocytic leukemia

Contacts and locations

Locations

  • ARGENTEUIL - Centre hospitalier Victor Dupouy

    Argenteuil, France

  • BOBIGNY - Hôpital Avicenne

    Bobigny, France

  • Bordeaux Pessac

    Pessac, 33604, France

  • CENTRE HOSPITALIER SAINTJEAN - Hématologie Clinique

    Perpignan, 66000, France

  • CERGY-PONTOISE - Centre Hospitalier René Dubos

    Pontoise, France

  • CHR ORLEANS - Hématologie

    Orléans, 44100, France

  • CHU Estaing - Hématologie Clinique Adulte

    Clermont-Ferrand, 63000, France

  • CHU Grenoble - Hématologie

    Grenoble, 388043, France

  • CHU Nancy Brabois

    Vandœuvre-lès-Nancy, 54500, France

  • CHU Pontchaillou - Hématologie Clinique BMT-HC

    Rennes, 35033, France

  • Centre Henri Becquerel - Service Hématologie Clinique

    Rouen, 76038, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495, France

  • Centre Hospitalier Regional Metz Thionville

    Metz, 57085, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre Léon Bérard - Hématologie

    Lyon, 69373, France

  • Ch Avignon

    Avignon, 84000, France

  • Ch Cote Basque

    Bayonne, 64109, France

  • Chu Angers

    Angers, 49933, France

  • Chu Reims

    Reims, 51092, France

  • Corbeil-Essonnes -

    Corbeil-Essonnes, France

  • Hopital E.Muller

    Mulhouse, 68100, France

  • Hopital Pitie Salpetriere Service Hematologie Clinique - Pavillon de L'Enfant Et Adolescent

    Paris, 75651, France

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044, France

  • Hôpital Privé Sévigné

    Cesson-Sévigné, 35510, France

  • Hôpital Saint Vincent de Paul

    Lille, 59000, France

  • Hôpital Saint-Eloi - Hématologie Clinique

    Montpellier, 34295, France

  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

    Poitiers, 86021, France

  • IUCT ONCOPOLE - Hématologie

    Toulouse, 31059, France

  • Institut Paoli-Calmettes - Hématologie Clinique

    Marseille, 13273, France

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271, France

  • VERSAILLES - Hôpital André Mignot

    Versailles, France

  • Vannes - Chba

    Vannes, France

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