Tailored chemo dosing shows promise for adult leukemia

NCT ID NCT00136435

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 ยท Last updated Jun 27, 2026

Summary

This phase II study tested a personalized dosing approach for the chemotherapy drug L-asparaginase in 100 adults aged 18-50 with newly diagnosed acute lymphoblastic leukemia (ALL). The goal was to see if adjusting doses based on individual drug levels could help more patients complete all 30 planned doses safely. Participants also received other standard chemotherapy drugs. The study measured how many patients finished the full course of L-asparaginase and tracked disease-free survival over four years.

What this could mean

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

Active substance
L-asparaginase
What this could lead to
If successful, this could lead to a safer and more effective way to give L-asparaginase to adults with ALL, potentially improving survival rates.
What could go wrong
This is a phase II trial with only 100 participants, so results may not apply to all patients. The treatment involves multiple chemotherapy drugs with known side effects like infection and organ damage.

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

100 people

The number who actually took part.

Start date

Jun 2002

Finished

May 2011

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

18 to 50 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: * Patients must have pathologically documented acute lymphoblastic leukemia, excluding mature B-cell ALL. * No prior therapy for leukemia with the following exceptions: * up to one week of steroids; * emergent leukapheresis; * emergency treatment for hyperleukocytosis with hydroxyurea; * cranial RT for CNS leukostasis (one dose only); * emergent radiation therapy to the mediastinum. * Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2. * Between the ages of 18 to 50 years. Exclusion Criteria: * Uncontrolled active infection. * Pregnancy or nursing mothers. * Prior history of pancreatitis. * Prior history of a cerebrovascular accident or hemorrhage. * Evidence of infection with the human immunodeficiency virus. * Active psychiatric or mental illness making informed consent or careful clinical follow-up unlikely. * The treating physician should consider all relevant medical and other considerations when deciding whether this protocol is appropriate for a particular patient.

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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.

Contacts and locations

Locations

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02115, United States

  • Hospital Maisonneuve-Rosemont

    Montreal, Quebec, Canada

  • London Health Sciences Centre

    London, Ontario, Canada

  • Manitoba Blood & Marrow Transplant Program CancerCare Manitoba

    Winnipeg, Manitoba, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02115, United States

  • McMaster University Medical Center

    Hamilton, Ontario, Canada

  • Queen Elizabeth II

    Halifax, Canada

  • Queen's University

    Kingston, Ontario, Canada

  • Royal Victoria Hospital

    Montreal, Quebec, Canada

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, Canada

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, Canada

  • University Of Columbia Medical Center

    New York, New York, United States

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