Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
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 ALL that has not responded to previous treatment or has come back after a response or chronic myeloid leukemia (CML).
Leukemia, Lymphocytic, Acute
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage|
- Complete Response (CR) Rate [ Time Frame: 6 cycles (cycle = 28 days) ] [ Designated as safety issue: Yes ]Complete Remission (CR): Normalization of peripheral blood and bone marrow with 5% or less blasts in a normocellular or hypercellular marrow with a granulocyte count of 1 x 109/L or above and platelet count of 100 x 109/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
|Study Start Date:||March 2009|
|Study Completion Date:||February 2015|
|Primary Completion Date:||February 2015 (Final data collection date for primary outcome measure)|
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
200 mg/m^2 by vein on days 1 and 15.
Other Name: RheumatrexDrug: Vincristine
1.4 mg/m^2 by vein (maximum dose 2 mg) on days 1, 8 and 15.
Other Name: Oncovin®Drug: PEG-l-asparaginase
2500 International units/m^2 by vein on days 2 and 16
Other Names:Drug: Dexamethasone
40 mg by vein or by mouth daily days 1-4 and 15-18.
Other Name: Decadron®Drug: Rituximab
Rituximab 375 mg/m^2 by vein on days 1 and 15 (first 4 cycles) for patients CD20 positive or positive by immunostain.
Other Name: Rituxan®
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00905034
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gautam Borthakur, M.D.||M.D. Anderson Cancer Center|