Tailored chemo dosing shows promise for adult leukemia
NCT ID NCT00136435
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute lymphoblastic leukemia are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Impact of aloe vera mouthwash on the prevention and severity of oral mucositis in adults in with hematologic malignancies
- Can a Chemo-Only prep beat radiation for childhood leukemia transplants?
- Can a targeted drug hit the mark in Hard-to-Treat blood cancers?
- Can a new drug combo boost remission in adult leukemia?
- Can a new combo drug tame childhood leukemia that Won't quit?
- Can a Low-Dose antifungal shield vulnerable patients from deadly fungal infections?