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Targeted therapy combo aims to improve survival in older leukemia patients

NCT ID NCT03249870

Disease control Sponsor: Versailles Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether adding the targeted drug inotuzumab ozogamicin to a milder chemotherapy regimen improves survival in adults over 55 with a specific type of acute lymphoblastic leukemia (ALL) that is Philadelphia chromosome-negative and CD22-positive. Participants receive the drug during the first two treatment cycles only, followed by standard chemotherapy. The main goal is to see how many patients are alive 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
inotuzumab ozogamicin
What this could lead to
If successful, this combination could offer a more effective and less toxic treatment option for older adults with this leukemia, potentially improving survival rates.
What could go wrong
This is a phase 2 study, so results are preliminary. The drug may cause side effects like liver toxicity or infections, and the benefit may not be confirmed in larger trials.

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

131 people

The number who actually took part.

Started

Dec 2017

Finished

Oct 2024

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

55 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: * Patients aged more than 55 years old, * With confirmed diagnosis of BCP-ALL according to World Health Organisation (WHO) criteria expressing the CD22 antigen by flow cytometry (20% or more positive blast cells), * Without central nervous system (CNS) involvement, * Without BCR-ABL fusion by standard cytogenetics, Fluorescence In Situ Hybridization (FISH) analysis and/or RT-PCR, * Previously untreated, * Eligible to intensive chemotherapy, due to general health status, * ECOG performance status ≤ 2, * Patients must have the following laboratory values unless considered due to leukemia: AST and ALT ≤ 2.5 x upper the limit of normal (ULN); estimated GFR ≥ 50 mL/min using the MDRD equation; total and direct serum bilirubin ≤ 1.5 x ULN; electrolyte panel within normal ranges for the institution unless attributed to the underlying disease. * Written informed consent obtained prior to any screening procedures. * Eligible for National Health Insurance in France. Exclusion Criteria: * Concurrent therapy with any other investigational agent or cytotoxic drug, * Prior documented chronic liver disease, * Active Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) or positive HIV serology, * Female patients who are pregnant or breast feeding or patients of childbearing potential not willing to use a double barrier method of contraception during the study and for 3 months following the last dose of maintenance. * Male patients whose sexual partner(s) are women of childbearing potential who are not willing to use a double barrier method of contraception, one of which includes a condom, during the study and for 3 months following the last dose of maintenance. * Any of concurrent severe and/or uncontrolled medical condition, which could compromise participation in the study.

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Conditions

The condition(s) this trial relates to.

Philadelphia Chromosome precursor B-cell acute lymphoblastic leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia (ALL) - philadelphia chromosome (PH)-negative CD22+ B-cell precursor (BCP)

Contacts and locations

Locations

  • CH Amiens sud

    Amiens, France

  • CH Lyon Sud

    Pierre-Bénite, France

  • CH Meaux

    Meaux, France

  • CH Montpellier

    Montpellier, France

  • CH Reims

    Reims, France

  • CH Rene Dubois

    Cergy-Pontoise, France

  • CH Roubaix

    Roubaix, France

  • CH Valenciennes

    Valenciennes, France

  • CH Versailles

    Le Chesnay, France

  • CH Victor Dupouy

    Argenteuil, France

  • CH cote basque

    Bayonne, France

  • CH metropole Savoie_ chambery

    Chambéry, France

  • CHR Orléans

    Orléans, France

  • CHRU Nancy

    Vandœuvre-lès-Nancy, France

  • CHU Angers

    Angers, France

  • CHU Besançon

    Besançon, France

  • CHU Caen

    Caen, France

  • CHU Clermond Ferrand

    Clermont-Ferrand, France

  • CHU Grenoble

    Grenoble, France

  • CHU Haut Leveque

    Pessac, France

  • CHU Limoges

    Limoges, France

  • CHU Nantes

    Nantes, France

  • CHU Nice

    Nice, France

  • CHU Nimes

    Nîmes, France

  • CHU Pontchaillou

    Rennes, France

  • CHU Strasbourg

    Strasbourg, France

  • CHU la Reunion

    La Réunion, France

  • Centre H Becquerel Rouen

    Rouen, France

  • Centre Lacassagne

    Nice, France

  • Centre Leon Berard

    Lyon, France

  • HIA Percy

    Clamart, France

  • Hopital Avicenne

    Bobigny, France

  • Hopital Dijon

    Dijon, France

  • Hopital Duchenne

    Boulogne-sur-Mer, France

  • Hopital Mondor

    Créteil, France

  • Hopital Necker

    Paris, France

  • Hopital St Antoine

    Paris, France

  • Hopital St Louis

    Paris, France

  • IPC

    Marseille, France

  • IUCT Oncopole

    Toulouse, France

  • Institut de cancerologie

    Saint-Priest-en-Jarez, France