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Major study finds safer way to give key leukemia drug to kids

NCT ID NCT00400946

Disease control Sponsor: Dana-Farber Cancer Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This study looked at 800 children with acute lymphoblastic leukemia to compare two forms of the drug asparaginase: a pegylated version given through a vein and a standard version given as a shot. The goal was to see which caused fewer serious side effects like allergic reactions, pancreatitis, or blood clots, while still controlling the leukemia. Results help doctors choose the best treatment to keep the disease in check.

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

800 people

The number who actually took part.

Started

Apr 2005

Finished

Jun 2019

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

1 year to 18 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.

DISEASE CHARACTERISTICS: * Diagnosis of acute lymphoblastic leukemia (ALL) * No known mature B-cell ALL, defined by the presence of any of the following: * Surface immunoglobulin * L3 morphology * t(8;14)(q24;q32) * t(8;22) * t(2;8) * T-cell surface markers and t(8;14)(q24;q11) allowed * No secondary ALL PATIENT CHARACTERISTICS: * No known HIV positivity * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: * No prior therapy except steroids of ≤ 1 week in duration and/or emergent radiation therapy to the mediastinum * Patients treated with steroids within the past 7 days will not receive steroid prophase during study treatment

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia Drug-Related Side Effects and Adverse Reactions leukemia Precursor Cell Lymphoblastic Leukemia-Lymphoma

As listed by the trial registrant

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

Drug/agent toxicity by tissue/organ Leukemia

Contacts and locations

Locations

  • Albert Einstein Cancer Center at Albert Einstein College of Medicine

    The Bronx, New York, 10461, United States

  • Centre de Recherche du Centre Hospitalier de l'Universite Laval

    Sainte-Foy, Quebec, GIV 4G2, Canada

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center

    New York, New York, 10032, United States

  • Hopital Sainte Justine

    Montreal, Quebec, H3T 1C5, Canada

  • James P. Wilmot Cancer Center at University of Rochester Medical Center

    Rochester, New York, 14642, United States

  • McMaster Children's Hospital at Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5, Canada

More trials for these conditions

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