Status:
COMPLETED
Intensified Post Remission Therapy Containing PEG-Asparaginase
Lead Sponsor:
University of Southern California
Conditions:
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief Summary
This study is for patients with recently diagnosed blood cancer, called acute lymphoblastic leukemia (ALL). The standard treatment for this disease consists of many chemotherapy drugs that are given i...
Eligibility Criteria
Inclusion
- Patients with previously untreated ALL subtypes L1 and L2.
- Patients with de novo Philadelphia (Ph)+ ALL (i.e. excluding those that are after blastic of CML) are eligible. However they will be referred to allogeneic hematopoietic stem cell transplantation and will continue on the study until they are ready to undergo the transplantation. At that time they will discontinue the study. Patients who are unable to undergo allogeneic transplantation will continue on the study.
- Presence of 25% or more of lymphoblasts in the bone marrow by FAB criteria, confirmed by TdT positivity or by flow cytometry with standard ALL markers.
- Patients may have received prior steroids.
- Age: 18 - 55 years
- Signed Informed Consent
Exclusion
- Patients with Burkitt's ALL (L3 subtype) or CML lymphoblastic crisis are not eligible (including CML patients who present with ALL blastic crisis).
- Psychological or emotional disorders which will make a valid informed consent impossible.
- Bilirubin \>1.5 mg/dl, creatinine \> 2.5 mg/dl
- Symptomatic congestive heart failure or unstable angina
- Pregnant or lactating females
- Known HIV positive status
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00184041
Start Date
July 1 2004
End Date
December 1 2012
Last Update
May 22 2014
Active Locations (1)
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1
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90032