Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
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|ClinicalTrials.gov Identifier: NCT00905034|
Recruitment Status : Completed
First Posted : May 20, 2009
Results First Posted : June 29, 2015
Last Update Posted : June 29, 2015
|Condition or disease||Intervention/treatment||Phase|
|Leukemia, Lymphocytic, Acute||Drug: Methotrexate Drug: Vincristine Drug: PEG-l-asparaginase Drug: Dexamethasone Drug: Rituximab||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage|
|Study Start Date :||March 2009|
|Primary Completion Date :||February 2015|
|Study Completion Date :||February 2015|
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®
- Complete Response (CR) Rate [ Time Frame: 6 cycles (cycle = 28 days) ]Rate calculated as number of participants with CR. Complete Remission (CR) defined as 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 10^9/L or above and platelet count of 100 x 10^9/L or above. Complete resolution of all sites of extramedullary disease is required for CR.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|