Status:
COMPLETED
A Study in Adults With Untreated Acute Lymphoblastic Leukemia
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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.
Detailed Description
This study has four treatment phases: 1) induction, 2) central nervous system therapy, 3) intensification, and 4) continuation. The induction phase lasts one month and eight drugs are used during thi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00136435
Start Date
June 1 2002
End Date
May 1 2011
Last Update
October 20 2025
Active Locations (12)
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1
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
2
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
3
University Of Columbia Medical Center
New York, New York, United States
4
Manitoba Blood & Marrow Transplant Program CancerCare Manitoba
Winnipeg, Manitoba, Canada