A Study in Adults With Untreated Acute Lymphoblastic Leukemia
Completed · Phase 2
Conditions studied: Acute Lymphoblastic Leukemia
In brief
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.
Key facts
- Study ID
- NCT00136435
- Run by
- Dana-Farber Cancer Institute
- People needed
- 100
- Starts
- 2002-06-01
- Expected to finish
- 2011-05-01
- Last updated by the study team
- 2025-10-20
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- University Of Columbia Medical Center — New York, New York, United States
- Manitoba Blood & Marrow Transplant Program CancerCare Manitoba — Winnipeg, Manitoba, Canada
- McMaster University Medical Center — Hamilton, Ontario, Canada
- Queen's University — Kingston, Ontario, Canada
- London Health Sciences Centre — London, Ontario, Canada
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
- Hospital Maisonneuve-Rosemont — Montreal, Quebec, Canada
- Royal Victoria Hospital — Montreal, Quebec, Canada
- Saskatoon Cancer Centre — Saskatoon, Saskatchewan, Canada
- Queen Elizabeth II — Halifax, Canada
Full record on ClinicalTrials.gov
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