CompletedPhase 2

A Study in Adults With Untreated Acute Lymphoblastic Leukemia

United States, Canada100 participantsStarted 2002-06

Plain-language summary

The purpose of this study is to determine the safety and optimal dosing of L-asparaginase in adult patients with acute lymphoblastic leukemia (ALL) between the ages of 18 and 50 years.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Asparaginase Completion Rate

Timeframe: Assessed at the end of the 30-week post-induction treatment period or when the participant comes off treatment, whichever occurs first.

Trial details

NCT IDNCT00136435

SponsorDana-Farber Cancer Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2008-11

Results submitted2025-04-03

View on ClinicalTrials.gov More Acute Lymphoblastic Leukemia trials

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.