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New drug combo for kids with tough leukemia shows promise but trial halted early

NCT ID NCT03860844

Disease control Sponsor: Sanofi 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Updated 1 time

Summary

This trial tested the drug isatuximab, a targeted antibody, combined with standard chemotherapy in children aged 28 days to under 18 years whose acute leukemia had returned or stopped responding to treatment. The study aimed to see if the combination could help more children achieve complete remission. However, the trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
isatuximab (a targeted antibody) combined with standard chemotherapy drugs
What this could lead to
If successful, this combination could offer a new treatment option for children with hard-to-treat leukemia that has returned or not responded to prior therapy.
What could go wrong
The trial was terminated early, so results are limited. It is a small, single-arm study, and the added benefit of isatuximab over chemotherapy alone is not yet proven.

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

67 people

The number who actually took part.

Started

Aug 2019

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

28 days to 17 years

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: * Participant 28 days to less than 18 years of age, at the time of signing the informed consent. * Participants must have had a confirmed diagnosis of relapsed Acute Lymphoblastic Leukemia (ALL) of T- or B-cell origin including T-lymphoblastic lymphoma (LBL), or relapsed Acute Myeloblastic Leukemia (AML) including participants with history of myelodysplasia. * Participants must have been previously treated for their disease and have relapsed or are refractory to most recent treatment. Participants in first or second relapse were eligible regardless of the remission duration. * Participants who had no more than 1 prior salvage therapy. * White Blood Cell (WBC) counts below 20 x10\^9/L on Day 1 before isatuximab administration Exclusion criteria: * Any serious active disease or co-morbid condition which, in the opinion of the Investigator, may interfere with the safety of the study treatment or the compliance with the study protocol. * Participants must have been off prior treatment with immunotherapy/investigational agents and chemotherapy for \>2 weeks and must have recovered from acute toxicity before the first study treatment administration. Exceptions were participants who needed to receive cytoreductive chemotherapy in order to decrease tumor burden (the study treatment may have started earlier if necessitated by the patient's medical condition (eg, rapidly progressive disease) following discussion with the Sponsor). * Prior stem cell transplant within 3 months and/or evidence of active systemic Graft versus Host Disease (GVHD) and/or immunosuppressive therapy for GVHD within 1 week before the first study treatment administration. * Participants with LBL with bone marrow blasts \<5%. * Participants with Burkitt-type ALL. * Acute leukemia with testicular or central nerve system involvement alone. * Participants who had developed therapy related acute leukemia. * Live vaccine(s) within 30 days prior to the first IMP administration or plans to receive such vaccines during the study until 90 days after the last IMP administration. * Participants with white blood cell count \> 50 x10\^9/L at the time of screening visit. * Participants who had been exposed to anti-CD38 therapies within 6 months prior to Day-1. The above information was not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia acute myeloid leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma T-lymphoblastic lymphoma

As listed by the trial registrant

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

Acute lymphoblastic leukemia Acute myeloid leukemia

Contacts and locations

Locations

  • Children's Medical Center of Dallas-Site Number:8400002

    Dallas, Texas, 75235, United States

  • Investigational Site Number :0320002

    CABA, Buenos Aires, C1181ACH, Argentina

  • Investigational Site Number :0320004

    Buenos Aires, C1245AAM, Argentina

  • Investigational Site Number :0320005

    Buenos Aires, C1118AAT, Argentina

  • Investigational Site Number :0320006

    Capital Federal, Buenos Aires, C1425DUC, Argentina

  • Investigational Site Number :0760001

    São Paulo, São Paulo, 08270-070, Brazil

  • Investigational Site Number :0760004

    São Paulo, São Paulo, 4023-062, Brazil

  • Investigational Site Number :0760006

    Curitiba, Paraná, 81520-060, Brazil

  • Investigational Site Number :0760007

    Porto Alegre, Rio Grande do Sul, 90035 003, Brazil

  • Investigational Site Number :0760009

    Ribeirão Preto, São Paulo, 14048-900, Brazil

  • Investigational Site Number :0760010

    Jaú, São Paulo, 17210-070, Brazil

  • Investigational Site Number :0760013

    Curitiba, Paraná, 80250-060, Brazil

  • Investigational Site Number :2080001

    Copenhagen, 2100, Denmark

  • Investigational Site Number :2500001

    Paris, 75571, France

  • Investigational Site Number :2500002

    Lille, 59037, France

  • Investigational Site Number :2500003

    Lyon, 69008, France

  • Investigational Site Number :2500004

    Paris, 75935, France

  • Investigational Site Number :2760003

    Hamburg, 20246, Germany

  • Investigational Site Number :2760005

    Erlangen, 91054, Germany

  • Investigational Site Number :2760006

    Münster, 48149, Germany

  • Investigational Site Number :3000001

    Athens, 115 27, Greece

  • Investigational Site Number :3480002

    Budapest, 1094, Hungary

  • Investigational Site Number :3800001

    Monza, Lombardy, 20900, Italy

  • Investigational Site Number :3800002

    Genoa, Liguria, 16147, Italy

  • Investigational Site Number :3800003

    Turin, Piedmont, 10126, Italy

  • Investigational Site Number :3800005

    Verona, Veneto, 37126, Italy

  • Investigational Site Number :4100001

    Seoul, Seoul-teukbyeolsi, 03080, South Korea

  • Investigational Site Number :4100002

    Seoul, Seoul-teukbyeolsi, 06351, South Korea

  • Investigational Site Number :4100004

    Seoul, Seoul-teukbyeolsi, 137-701, South Korea

  • Investigational Site Number :4840001

    Monterrey, Nuevo León, 64460, Mexico

  • Investigational Site Number :4840005

    Col. Rancho Menchaca, Querétaro, 76140, Mexico

  • Investigational Site Number :5280001

    Utrecht, 3584 CS, Netherlands

  • Investigational Site Number :5780001

    Bergen, 5021, Norway

  • Investigational Site Number :5780002

    Oslo, 0342, Norway

  • Investigational Site Number :6040001

    Arequipa, Peru

  • Investigational Site Number :6040002

    Lima, 34, Peru

  • Investigational Site Number :6200001

    Lisbon, 1099-023, Portugal

  • Investigational Site Number :6200002

    Coimbra, 3000-602, Portugal

  • Investigational Site Number :6200003

    Porto, 4200-162, Portugal

  • Investigational Site Number :7520001

    Gothenburg, 416 85, Sweden

  • Sarah Cannon Research Institute-Site Number:8400001

    Nashville, Tennessee, 37203, United States

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