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New hope for kids with aggressive leukemia relapse

NCT ID NCT03590171

Disease control Sponsor: Charite University, Berlin, Germany Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 drug bortezomib to standard chemotherapy helps more children with high-risk relapsed acute lymphoblastic leukemia (ALL) achieve remission. About 250 children under 18 with a first relapse of ALL will be randomly assigned to receive either standard chemo alone or chemo plus bortezomib. The goal is to improve remission rates and long-term survival.

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

About 250 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2017

Expected to finish

Dec 2027

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

Up 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: * Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL * Children less than 18 years of age at date of inclusion into the study * Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse) * Patient enrolled in a participating centre * Written informed consent * Start of treatment falling into the study period * No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL Exclusion Criteria: * Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL * Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \> 10 U/l) * Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy * Breast feeding * Relapse post allogeneic stem-cell transplantation * Neuropathy \> II° * The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian * Objection to the study participation by a minor patient, able to object * Any patient being dependent on the investigator * No consent is given for saving and propagation of pseudonymized medical data for study reasons * Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) * Subjects unwilling or unable to comply with the study procedures * Subjects who are legally detained in an official institute

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Conditions

The condition(s) this trial relates to.

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)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 15 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Australian & New Zealand Childhood Hematology & Oncology Group

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • CHU Nice

    RECRUITING

    Nice, France

  • Copenhagen University Hospital (Rigshospitalet)

    NOT_YET_RECRUITING

    Copenhagen, 2100, Denmark

  • Dpt. SCT and Hematology/Oncology University Wroclaw

    RECRUITING

    Wroclaw, 50354, Poland

  • Hòpital Universitaire des Enfants Reine Fabiola

    RECRUITING

    Brussels, 1020, Belgium

  • Instituto Português de Oncologia de Lisboa

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Oslo University Hospital

    NOT_YET_RECRUITING

    Oslo, 0027, Norway

  • Ospedale Pediatrico Bambino Gesù

    RECRUITING

    Roma, 00165, Italy

  • Prinses Máxima Centrum, Lundlaan

    RECRUITING

    Utrecht, Netherlands

  • Royal Manchester Children's Hospital

    NOT_YET_RECRUITING

    Manchester, M13 9WL, United Kingdom

  • St. Anna Kinderkrebsforschung, CCRI

    RECRUITING

    Vienna, 1090, Austria

  • Tel Aviv Sourasky Medical Centre

    RECRUITING

    Tel Aviv, 64239, Israel

  • Turku University Central Hospital

    RECRUITING

    Turku, SF-20520, Finland

  • University Hospital Motol

    RECRUITING

    Prague, Czechia

  • University Hospital Stockholm

    NOT_YET_RECRUITING

    Stockholm, 17176, Sweden

More trials for these conditions

Other studies related to the condition(s) this trial covers.