Status:
COMPLETED
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Leadiant Biosciences, Inc.
Conditions:
Leukemia, Lymphocytic, Acute
Eligibility:
All Genders
1+ years
Phase:
PHASE2
Brief Summary
This goal of this clinical research study is to learn if the combination of methotrexate, pegylated-L-asparaginase, vincristine, and dexamethasone (also rituximab in some patients) can help to control...
Detailed Description
The Study Drugs: Methotrexate is designed to disrupt cells from making and repairing DNA (the genetic material of cells) and "copying" themselves. Vincristine is designed to interfere with the multi...
Eligibility Criteria
Inclusion
- Previously treated ALL (including Burkitt's lymphoma) or lymphoblastic lymphoma in relapse or primary refractory; without viable stem cell transplant option. Patients with previously treated Philadelphia chromosome positive ALL will be also eligible;
- Chronic myeloid leukemia in blast phase
- Zubrod performance status \</= 3;
- Adequate liver function (bilirubin \</= 3.0mg/dl, unless considered due to tumor),and renal function (creatinine \</= 3.0 mg/dl unless considered due to tumor;
- Age \>/= to 1 year
- Understand and voluntarily sign an informed consent form.
- For pediatric patients (age \>/= 1 year to \</= 18 years), Lansky performance status \>/=50
- For pediatric patients (age \>/= 1 year to \</= 18 years), second or greater relapse
Exclusion
- Pregnant patients
- Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT00905034
Start Date
March 1 2009
End Date
February 1 2015
Last Update
June 29 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030