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New chemo drug could mean fewer shots for kids with leukemia

NCT ID NCT01574274

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This study compares two forms of the chemotherapy drug asparaginase in 240 children and teens with acute lymphoblastic leukemia or lymphoblastic lymphoma. One drug (Oncaspar) is given every 2 weeks, while the new drug (SC-PEG) is given every 3 weeks and may last longer in the blood. The study also looks at whether adjusting treatment based on minimal residual disease can improve cure rates, and whether giving antibiotics early can prevent serious infections.

What this could mean

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

Active substance
Calaspargase pegol (SC-PEG) and Oncaspar (both forms of the chemotherapy drug asparaginase)
What this could lead to
If it works, this could lead to a more convenient dosing schedule (every 3 weeks instead of every 2 weeks) with similar safety and effectiveness for children with ALL or lymphoblastic lymphoma.
What could go wrong
This is a Phase 2 trial, so results are still early. The new drug may not prove as safe or effective as the standard, and the study also tests changes in therapy based on minimal residual disease, which is not yet proven to improve cure rates.

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

240 people

The number who actually took part.

Start date

Jun 2012

Expected to finish

Jul 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

365 days to 21 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: * Confirmed diagnosis of ALL or lymphoblastic leukemia * No prior therapy except short courses of corticosteroids, a single dose of IT cytarabine or emergent radiation to the mediastinum or other life-threatening masses Exclusion Criteria: * Have received more than 7 days of corticosteroids in the preceding 4 weeks or more than 28 days of corticosteroids in the preceding 6 months * Have received any chemotherapy or radiotherapy for previous malignancy * Receiving any other investigational agent * Known to be HIV positive * Uncontrolled intercurrent illness * Pregnant or breastfeeding * History of previous malignancy

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Conditions

The condition(s) this trial relates to.

acute lymphoblastic leukemia lymphoblastic lymphoma 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 Lymphoblastic lymphoma

Contacts and locations

Locations

  • Centre Hospitalier U. de Quebec

    Québec, Quebec, Canada

  • Children's Hospital Boston

    Boston, Massachusetts, 02215, United States

  • Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian

    New York, New York, 10032, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Hasbro Children's Hospital

    Providence, Rhode Island, 02903, United States

  • Hospital Sainte Justine, University of Montreal

    Montreal, Quebec, Canada

  • McMaster University

    Hamilton, Ontario, Canada

  • Montefiore Medical Center

    New York, New York, 10467, United States

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