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Chemo-Free hope: new combo aims to outsmart CLL

NCT ID NCT04010968

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a combination of two targeted drugs, venetoclax and ibrutinib, against standard chemotherapy (FCR) in 120 fit patients with intermediate-risk chronic lymphocytic leukemia (CLL). The goal was to see if the drug combo could achieve deep remission with a fixed treatment duration, guided by minimal residual disease (MRD) testing. Participants received ibrutinib alone for 3 months, then added venetoclax, with treatment stopping if MRD levels were very low at month 9.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
venetoclax and ibrutinib
What this could lead to
If successful, this could offer a chemotherapy-free option for intermediate-risk CLL patients, potentially with a fixed treatment duration and better long-term outcomes.
What could go wrong
This is a phase 2 trial with only 120 participants, so results are preliminary. The targeted drugs may cause side effects like heart issues or infections, and the approach may not work for everyone.

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

120 people

The number who actually took part.

Started

Sep 2019

Finished

Jan 2025

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

18 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 18 years or older. * Immunophenotypically confirmed CLL (according to IWCLL guidelines, RMH score 4-5 or RMH 3 providing CD200high and CD20low), excluding small lymphocytic lymphoma without lymphocytosis. * Indication for treatment according to the 2018 IWCLL criteria and clinically measurable disease. * Risk stratification: no criteria characterizing low-risk or high-risk groups. * Patient with unmutated status * Absence of 17p deletion and/or TP53 mutation. * Performance status ECOG \< 2. * CIRS (Cumulative Illness Rating Scale) ≤ 6. * Eligibility for fludarabine, cyclophosphamide and rituximab combination (FCR) and for ibrutinib and venetoclax therapy. * Adequate hepatic function per local laboratory reference range as follows: * Aspartate transaminase (AST) and alanine transaminase (ALT) \< 3.0 x ULN * Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin). * No prior treatment for CLL (chemotherapy, radiotherapy, immuno-therapy) except steroids for less than 1 month. * Willingness to accept highly effective methods of contraception for the duration of therapy and 12 months thereafter. * Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[β-hCG\]) or urine pregnancy test at Screening. * 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 biomarkers, and are willing to participate in the study. Exclusion Criteria: * Patients with IGHV mutated (except VH3-21/subset #2) with normal karyotype and/or del 13q without TP53 mutation ie low risk patients. * Patients del 17p and or TP53 mutation ie high risk patients. * CLL without active disease according to IWCLL 2008 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) * Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIG) may participate. * Active and uncontrolled autoimmune cytopenia, including autoimmune hemolytic anemia (AIHA) (isolated positive DAT is not an exclusion criteria) and idiopathic thrombocytopenic purpura (ITP). * Life expectancy \< 6 months. * Patient refusal to perform the bone marrow biopsy for evaluation points. * Active second malignancy currently requiring treatment (except basal cell carcinoma, in situ endometrial carcinoma and incidental prostate carcinoma) and/or less than 5 years CR after breast cancer. * Concurrent severe diseases which exclude the administration of therapy. * heart insufficiency NYHA grade III/IV, LEVF \< 50% and or RF \<30%, myocardial infarction within the past 6 months prior to study. * severe chronic obstructive lung disease with hypoxemia. * severe diabetes mellitus. * hypertension difficult to control. * impaired renal function with creatinine clearance \< 50 ml/min according the formula of Cockcroft and Gault. * 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. * Contraindication to the use of Rituximab. * Contraindication to the use of Venetoclax. * Contraindication to the use of Ibrutinib. * Pregnant or breastfeeding women. * Adult under law-control. * Fertile male and female 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.

Fit patients Intermediate risk chronic lymphocytic leukemia Risk-adapted and MRD-driven strategy

Contacts and locations

Locations

  • Bordeaux Pessac

    Pessac, 33604, France

  • CH Annecy Genevois - Hématologie A3

    Annecy, 74374, France

  • CH BLOIS

    Blois, 41000, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHR ORLEANS - Hématologie

    Orléans, 44100, France

  • CHU Caen - IHBN - Hématologie Clinique

    Caen, 14033, France

  • CHU Estaing - Hématologie Clinique Adulte

    Clermont-Ferrand, 63000, France

  • CHU Grenoble - Hématologie

    Grenoble, 388043, France

  • CHU Hôtel Dieu - Hématologie Clinique

    Nantes, 44093, 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 Sud Francilien

    Corbeil-Essonnes, 91100, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre Léon Bérard - Hématologie

    Lyon, 69373, France

  • Ch Cote Basque

    Bayonne, 64109, France

  • Chu Creteil

    Créteil, 94000, France

  • Chu Reims

    Reims, 51092, France

  • GRENOBLE GHM - Institut Daniel Hollard

    Grenoble, 38028, France

  • Hôpital André Mignot

    Versailles, 78157, France

  • Hôpital Avicenne - Centre de Recherche Clinique

    Bobigny, 93009, France

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044, France

  • Hôpital Hautepierre - Hématologie

    Strasbourg, 67098, France

  • Hôpital Pitié Salpétrière - Hématologie

    Paris, 75651, France

  • Hôpital Privé Sévigné

    Cesson-Sévigné, 35510, France

  • Hôpital Saint Eloi

    Montpellier, 34295, France

  • Hôpital Saint Vincent de Paul

    Lille, 59000, France

  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

    Poitiers, 86021, France

  • IUCT ONCOPOLE - Hématologie

    Toulouse, 31059, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Paoli Calmette

    Marseille, 130009, France

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271, France

More trials for these conditions

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