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New drug combo takes aim at High-Risk leukemia

NCT ID NCT03734198

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 pilot study is testing whether combining two drugs, ibrutinib and daratumumab, can improve outcomes for people with relapsed or refractory chronic lymphocytic leukemia (CLL) that has a p53 gene problem. The 29 participants will take ibrutinib daily and receive daratumumab infusions on a schedule. The main goal is to see how many achieve a complete response within 12 months, while also monitoring safety.

What this could mean

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

Active substance
Ibrutinib and daratumumab
What this could lead to
If successful, this combination could offer a more effective treatment option for people with hard-to-treat CLL that has not responded to prior therapies.
What could go wrong
This is a small, early-phase pilot study with only 29 participants. The combination may not prove more effective than existing treatments and could cause side effects like infusion reactions or infections.

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

29 people

The number who actually took part.

Started

Dec 2018

Expected to finish

Dec 2025

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: * Immunophenotypically confirmed diagnosis of CLL (criteria iwCLL Hallek et al. 2018) * Progressive CLL according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria * Relapsed or refractory disease (≥ 1 previous line of treatment) with P53 genetic alteration (17p deletion and/or TP53 mutation). * Age \> 18 years * Eastern Cooperative Oncology Group electrocorticogram (ECOG) status 0-2 * Negative serum pregnancy test one week prior to treatment for premenopausal women * Cumulative Illness Rating Scale (CIRS) ≤ 6 * Life expectancy \> 3 months. * Possibility of follow-up * Ability to understand the protocol * Written informed consent of patient and treating physician Exclusion Criteria: * Previous treatment with ibrutinib. * Patient refusal to perform bone marrow biopsy for evaluation point * Prior other malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cancer, or other cancer from which the subject has been disease free for ≥ 2 years). * Known chronic obstructive pulmonary disease (COPD) with a Forced Expiratory Volume in 1 second (FEV1) \< 50 % of predicted normal. FEV testing is required for patients suspected of having COPD. * Moderate or severe persistent asthma within the two last years or currently uncontrolled asthma of any classification (American Lung Association criteria). Current controlled intermittent asthma or controlled mild persistent asthma is not an exclusion criterion. * Patients with active bacterial, viral, or fungal infection requiring systemic treatment. * Patients with known infection with human immunodeficiency virus (HIV) or human T-lymphotropic virus type 1 (HTLV-1) * Active B or C hepatitis (positive Hepatitis B Virus surface antigen (HBsAg) or Hepatitis B Virus (HBV) DNA for HBV; Positive Hepatitis C virus (HCV) RNA for HCV) * History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies. * Any other uncontrolled medical condition or comorbidity that might interfere with subject's participation. * Concomitant dual antiplatelet therapy * Concomitant treatment with both antiplatelet and anticoagulation therapy * Treatment with other investigational agent or participating to another trial within 30 days prior to entering the study * Hemoglobin \< 8 g/dL * Absolute neutrophil count (ANC) \< 1000/mm3 * Platelets \< 30000/mm3 * Inadequate renal function: creatinine clearance \< 50 ml/min (Cockcroft and Gault) * Inadequate liver function: Aspartate Transaminase (ASAT), Alanine aminotransferase (ALT) \> 2.5 x Upper Limit of Normal (ULN) * Total bilirubin \> 1.5 x ULN unless rise is due to Gilbert's syndrome or of non-hepatic origin. * Active auto-immune haemolytic anemia * Richter's transformation * Evidence of central nervous system (CNS) involvement * 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 affiliate to social security

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Recurrence

As listed by the trial registrant

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

Relapsed or refractory chronic lymphocytic leukemia

Contacts and locations

Locations

  • CH Annecy Genevois - Hématologie A3

    Annecy, 74374, France

  • CHD Vendée

    La Roche-sur-Yon, 85925, France

  • CHLS - Lyon Pierre Bénite - Service Hématologie

    Lyon, 69495, France

  • CHU Bordeaux - Hôpital Haut-Lévèque - CFM Maladies du sang

    Pessac, 33604, 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 Jean Minjoz - Hématologie

    Besançon, 25000, France

  • CHU Pontchaillou - Hématologie Clinique BMT-HC

    Rennes, 35033, France

  • Centre Henri Becquerel - Service Hématologie Clinique

    Rouen, 76038, France

  • Centre Hospitalier du Mans

    Le Mans, 72000, France

  • Centre Léon Bérard - Hématologie

    Lyon, 69373, France

  • Chu Amiens Sud

    Amiens, 80054, France

  • Hôpital Avicenne - Centre de Recherche Clinique

    Bobigny, 93009, France

  • Hôpital Bretonneau - Hématologie et Thérapie Cellulaire

    Tours, 37044, France

  • Hôpital Pitié Salpétrière - Hématologie

    Paris, 75651, France

  • Hôpital Robert Debré - Hématologie Clinique

    Reims, 51092, France

  • Hôpital Saint-Eloi - Hématologie Clinique

    Montpellier, 34295, France

  • Hôpital de la Milétrie - Hématologie et Thérapie Cellulaire

    Poitiers, 86021, France

  • Hôpitaux de Brabois - Hématologie Adulte

    Vandœuvre-lès-Nancy, 54511, France

  • ICANS

    Strasbourg, 67098, France

  • IUCT ONCOPOLE - Hématologie

    Toulouse, 31059, France

  • Institut Paoli-Calmettes - Hématologie Clinique

    Marseille, 13273, France

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