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Immunotherapy blinatumomab shows promise in kids with relapsed leukemia

NCT ID NCT02393859

Disease control Sponsor: Amgen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested the drug blinatumomab in 111 children with high-risk relapsed B-precursor acute lymphoblastic leukemia (ALL). Blinatumomab is an immunotherapy that helps the body's immune cells attack cancer cells. The study compared blinatumomab to standard chemotherapy as consolidation therapy after initial treatment. The goal was to see if blinatumomab could improve event-free survival (time without cancer returning) and overall survival.

What this could mean

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

Active substance
blinatumomab (Blincyto)
What this could lead to
If successful, this could offer a more effective and less toxic treatment option for children with relapsed acute lymphoblastic leukemia.
What could go wrong
This is a completed Phase 3 trial, but results may not apply to all patients. Blinatumomab can cause serious side effects like cytokine release syndrome and neurological problems.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

111 people

The number who actually took part.

Started

Nov 2015

Finished

Nov 2022

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

0 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: * Subjects with Philadelphia chromosome negative (Ph-) high-risk (HR) first relapse B-precursor acute lymphoblastic leukemia (ALL; as defined by International Berlin-Frankfurt-Muenster study group/International study for treatment of childhood relapsed ALL \[I-BFM SG/IntReALL\] criteria) * Subjects with bone marrow blast percentage \< 5% (M1) or bone marrow blast percentage \< 25% and ≥5% (M2) marrow at the time of randomization, * Age \> 28 days and \< 18 years at the time of informed consent/assent * Subject's legally acceptable representative has provided informed consent when the subject is legally too young to provide informed consent and the subject has provided written assent based on local regulations and/or guidelines prior to any study-specific activities/procedures being initiated * Availability of the following material from relapse diagnosis for central analysis of minimal residual disease (MRD) by polymerase chain reaction (PCR): clone-specific primers and reference deoxyribonucleic acid (DNA), as well as primer sequences and analyzed sequences of clonal rearrangements (cases with isolated extramedullary relapse or cases with technical and/or logistic hurdles to obtain and process bone marrow material are exempt from providing this material. In these cases, central MRD analysis only by Flow is permitted). Exclusion Criteria: * Clinically relevant central nervous system (CNS) pathology requiring treatment (eg, unstable epilepsy). Evidence of current CNS (CNS 2, CNS 3) involvement by ALL. Subjects with CNS relapse at the time of relapse are eligible if CNS is successfully treated prior to enrollment * Peripheral neutrophils \< 500/μL prior to start of treatment * Peripheral platelets \< 50,000/μL prior to start of treatment * Currently receiving treatment in another investigational device or drug study or less than 4 weeks since ending treatment on another investigational device or drug study(s), procedures required by IntReALL high-risk (HR) guidelines are allowed * Chemotherapy related toxicities that have not resolved to ≤ grade 2 (except for parameters defined in Exclusion Criteria 202, 203, 204, and 217) * Symptoms and/or clinical signs and/or radiological and/or sonographic signs that indicate an acute or uncontrolled chronic infection, any other concurrent disease or medical condition that could be exacerbated by the treatment or would seriously complicate compliance with the protocol * Abnormal renal or hepatic function prior to start of treatment (day 1) as defined below * Abnormal serum creatinine based on age/gender * Total bilirubin \> 3.0 mg/dL prior to start of treatment (unless related to Gilbert's or Meulengracht disease) * Documented infection with human immunodeficiency virus (HIV) * Known hypersensitivity to immunoglobulins or any of the products or components to be administered during dosing (excluding asparaginase) * Post-menarchal female subject who is pregnant or breastfeeding, or is planning to become pregnant or breastfeed while receiving protocol-specified therapy and for at least 12 months after the last dose of chemotherapy * Post-menarchal female subject who is not willing to practice true sexual abstinence or use a highly effective form of contraception while receiving protocol-specified therapy and for at least 12 months after the last dose of chemotherapy * Sexually mature male subject who is not willing to practice true sexual abstinence or use a condom with spermicide while receiving protocol-specified therapy and for at least 6 months after last dose of chemotherapy. In countries where spermicide is not available, a condom without spermicide is acceptable * Sexually mature male subject who is not willing to abstain from sperm donation while receiving protocol-specified therapy and for at least 6 months after last dose of chemotherapy * Subject likely to not be available to complete all protocol-required study visits or procedures, including follow-up visits, and/or to comply with all required study procedures to the best of the subject's and investigator's knowledge * History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion * Placed into an institution due to juridical or regulatory ruling.

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Conditions

The condition(s) this trial relates to.

immunoproliferative disorder lymphoblastic leukemia, acute, with lymphomatous features lymphoproliferative syndrome neoplasm 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.

Leukemia, acute lymphoblastic

Contacts and locations

Locations

  • Research Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1199ABB, Argentina

  • Research Site

    Randwick, New South Wales, 2031, Australia

  • Research Site

    Westmead, New South Wales, 2145, Australia

  • Research Site

    South Brisbane, Queensland, 4101, Australia

  • Research Site

    Parkville, Victoria, 3052, Australia

  • Research Site

    Graz, 8036, Austria

  • Research Site

    Innsbruck, 6020, Austria

  • Research Site

    Vienna, 1090, Austria

  • Research Site

    Brussels, 1020, Belgium

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Liège, 4000, Belgium

  • Research Site

    Curitba, Paraná, 81520-060, Brazil

  • Research Site

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Research Site

    São Paulo, São Paulo, 04039-001, Brazil

  • Research Site

    São Paulo, São Paulo, 08270-070, Brazil

  • Research Site

    Prague, 150 06, Czechia

  • Research Site

    København Ø, 2100, Denmark

  • Research Site

    Bordeaux, 33076, France

  • Research Site

    Lille, 59037, France

  • Research Site

    Lyon, 69008, France

  • Research Site

    Marseille, 13385, France

  • Research Site

    Montpellier, 34295, France

  • Research Site

    Nantes, 44093, France

  • Research Site

    Paris, 75012, France

  • Research Site

    Paris, 75019, France

  • Research Site

    Strasbourg, 67200, France

  • Research Site

    Vandœuvre-lès-Nancy, 54511, France

  • Research Site

    Berlin, 13353, Germany

  • Research Site

    Düsseldorf, 40225, Germany

  • Research Site

    Erlangen, 91054, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Frankfurt am Main, 60590, Germany

  • Research Site

    Freiburg im Breisgau, 79106, Germany

  • Research Site

    Giessen, 35392, Germany

  • Research Site

    Hamburg, 20246, Germany

  • Research Site

    Hanover, 30625, Germany

  • Research Site

    Jena, 07740, Germany

  • Research Site

    Kiel, 24105, Germany

  • Research Site

    München, 80337, Germany

  • Research Site

    Münster, 48149, Germany

  • Research Site

    Tübingen, 72076, Germany

  • Research Site

    Ulm, 89075, Germany

  • Research Site

    Würzburg, 97080, Germany

  • Research Site

    Goudi, 11527, Greece

  • Research Site

    Haifa, 3109601, Israel

  • Research Site

    Jerusalem, 9112001, Israel

  • Research Site

    Petah Tikva, 4920235, Israel

  • Research Site

    Tel Aviv, 6423906, Israel

  • Research Site

    Tel Litwinsky, 5262000, Israel

  • Research Site

    Bologna, 40138, Italy

  • Research Site

    Genova, 16147, Italy

  • Research Site

    Monza (MB), 20900, Italy

  • Research Site

    Naples, 80123, Italy

  • Research Site

    Padova, 35128, Italy

  • Research Site

    Pavia, 27100, Italy

  • Research Site

    Roma, 00161, Italy

  • Research Site

    Roma, 00165, Italy

  • Research Site

    Torino, 10126, Italy

  • Research Site

    Guadalajara, Jalisco, 44340, Mexico

  • Research Site

    Mexico City, Mexico City, 01120, Mexico

  • Research Site

    Monterrey, Nuevo León, 64460, Mexico

  • Research Site

    Rotterdam, 3015 CN, Netherlands

  • Research Site

    Utrecht, 3584 CS, Netherlands

  • Research Site

    Oslo, 0372, Norway

  • Research Site

    Bydgoszcz, 85-094, Poland

  • Research Site

    Krakow, 30-663, Poland

  • Research Site

    Lublin, 20-093, Poland

  • Research Site

    Wroclaw, 50-556, Poland

  • Research Site

    Zabrze, 41-800, Poland

  • Research Site

    Lisbon, 1099-023, Portugal

  • Research Site

    Porto, 4200-072, Portugal

  • Research Site

    Bucharest, 022328, Romania

  • Research Site

    Cluj-Napoca, 400177, Romania

  • Research Site

    Moscow, 115478, Russia

  • Research Site

    Saint Petersburg, 197022, Russia

  • Research Site

    Málaga, Andalusia, 29011, Spain

  • Research Site

    Seville, Andalusia, 41013, Spain

  • Research Site

    Santander, Cantabria, 39008, Spain

  • Research Site

    Barcelona, Catalonia, 08035, Spain

  • Research Site

    Barcelona, Catalonia, 08041, Spain

  • Research Site

    Santiago de Compostela, Galicia, 15706, Spain

  • Research Site

    Boadilla del Monte, Madrid, 28660, Spain

  • Research Site

    El Palmar, Murcia, 30120, Spain

  • Research Site

    Valencia, Valencia, 46026, Spain

  • Research Site

    Madrid, 28009, Spain

  • Research Site

    Madrid, 28046, Spain

  • Research Site

    Stockholm, 171 76, Sweden

  • Research Site

    Basel, 4056, Switzerland

  • Research Site

    Zurich, 8032, Switzerland

  • Research Site

    Adana, 01130, Turkey (Türkiye)

  • Research Site

    Antalya, 07059, Turkey (Türkiye)

  • Research Site

    Izmir, 35040, Turkey (Türkiye)

  • Research Site

    Kayseri, 38039, Turkey (Türkiye)

  • Research Site

    Birmingham, B4 6NH, United Kingdom

  • Research Site

    Bristol, BS2 8BJ, United Kingdom

  • Research Site

    Glasgow, G51 4TF, United Kingdom

  • Research Site

    London, WC1N 3JH, United Kingdom

  • Research Site

    Manchester, M13 9WL, United Kingdom

  • Research Site

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Research Site

    Sheffield, S10 2TH, United Kingdom

  • Research Site

    Sutton, SM2 5PT, United Kingdom

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