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

NCT ID NCT03860844

Terminated Disease control Sponsor: Sanofi Source: ClinicalTrials.gov ↗

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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