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|
|Actual Primary Completion Date :||February 2015|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|