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New drug shows promise in Early-Stage High-Risk leukemia trial

NCT ID NCT03766763

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase II trial tests the drug venetoclax as an early treatment for people with high-risk chronic lymphocytic leukemia (CLL) that hasn't caused symptoms yet. About 82 participants will take venetoclax daily for up to 18 months. The goal is to see if the drug can wipe out nearly all cancer cells in the bone marrow after one year.

What this could mean

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

Active substance
Venetoclax (a targeted drug that blocks a protein helping cancer cells survive)
What this could lead to
If successful, this could offer a way to treat high-risk CLL early, potentially delaying disease progression and reducing the need for stronger therapies.
What could go wrong
This is a small, early-phase trial (82 people) with no control group, so results may not apply broadly. Venetoclax can cause side effects like tumor lysis syndrome and low blood counts.

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 82 people

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

Started

May 2019

Expected to finish

Apr 2030

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

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: * Established diagnosis of Chronic Lymphoid Leukemia by International Workshop Chronic Lymphoid Leukemia 2008 criteria with Matutes score Superior to 3, or Matutes score egal to 3 with CD200 positive and CD20 low * High risk Binet stage A, patients presenting at least 2 from 3 risk factors: Lymphocytosis Superior to 13 Giga per liter, CD38 positive, beta2 microglobulin Superior to 2.5 milligram per liter. Only patients with unmutated status will be treated and followed according to the trial. * No prior chemotherapy, radiation or antibody treatment * Age Superior to 18 years * Life expectancy Superior to 6 months * Performance status 0 to 2 * All parameters for risk stratification present * Possibility of follow-up * Adequate hepatic function per local laboratory reference range as follows: Aspartate transaminase and alanine transaminase Superior to 3.0 of upper limit of normal and Bilirubin inferior or egal to 1.5 of upper limit of normal (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin). * 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) or urine pregnancy test at Screening. * Sign (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: * Binet Stage A patients with progressive disease according to International Workshop Chronic Lymphoid Leukemia 2008 criteria * Clinically apparent autoimmune cytopenia, in particular antiglobulin test positive hemolytic anemia (positive antiglobulin test without anemia is not an exclusion criteria) * Active secondary malignancy or chemotherapy/radiotherapy for any neoplastic disease other than Chronic Lymphoid Leukemia prior to the study * Medical condition requiring the long term (estimated to be more than one month) use of oral corticosteroids * Patient refusal to perform the bone marrow biopsy for evaluation points * Patients with active bacterial, viral or fungal infection * Subject is known to be positive for Human Immunodeficiency Virus * Evidence of other clinically significant uncontrolled conditions * Treatment with any other investigational agent or participating in another trial within 30 days prior to entering this study * A female patient who is pregnant or breast feeding * Concurrent severe diseases which exclude the administration of therapy * Richter's syndrome * Treatment with any of the following within 7 days prior to the first dose of study drug: Steroid therapy for anti-neoplastic intent, moderate or strong cytochrome P450 3A inhibitors, moderate or strong cytochrome P450 3A inducers * Administration or consumption of any of the following within 3 days prior to the first dose of study drug: grapefruit or grapefruit products, Seville oranges, star fruit. * Prior and concomitant therapy * Malabsorption syndrome or other condition that precludes enteral route of administration * Received a live viral vaccination within 6 months prior to the first dose of study drug. 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 * Not affiliated to social security

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Leukemia, B-Cell

As listed by the trial registrant

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

Chronic lymphoid leukemia

Contacts and locations

Locations

  • Bordeaux Pessac

    Pessac, 33604, France

  • CH BLOIS

    Blois, 41000, France

  • CHU CAEN

    Caen, 14033, 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 leon berard

    Lyon, 69008, France

  • Ch Annecy

    Annecy, 74374, France

  • Ch Beziers

    Béziers, 34500, France

  • Ch Cote Basque

    Bayonne, 64109, France

  • Chd Le Mans

    Le Mans, 72000, France

  • Chd Vendee

    La Roche-sur-Yon, 85925, France

  • Chu Amiens

    Amiens, 80054, France

  • Chu Angers

    Angers, 49933, France

  • Chu Creteil

    Créteil, 94000, France

  • Chu Estaing

    Clermont-Ferrand, 63000, France

  • Chu Grenoble

    Grenoble, 38043, France

  • Hopital Huriez

    Lille, 59037, France

  • Hopitaljean Minjoz

    Besançon, 25000, France

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044, France

  • Hôpital Privé Sévigné

    Cesson-Sévigné, 35510, France

  • Institut Bergonie

    Bordeaux, 33076, France

  • Institut Paoli Calmette

    Marseille, 130009, France

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