Phase II study of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone (MOAD) in acute lymphoblastic leukemia (ALL) salvage and Chronic Myeloid Leukemia (CML) in blast phase
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 CML.
Disease Group: Leukemia
Treatment Agent: Dexamethasone
Treatment Location: Only at MD Anderson
Estimatated Length of Stay in Houston: not applicable
Sponsor: Sigma-Tau Pharmaceuticals, Inc.
Return Visit: minimum of one time a week for the first two weeks 1-3 months thereafter.
Home Care: Treatment beyond first two weeks can be received by local oncologist.
To determine the efficacy and safety of a chemotherapy regimen comprising of methotrexate, vincristine, pegylated L-asparaginase and dexamethasone in acute lymphoblastic leukemia (ALL) salvage or chronic myeloid leukemia (CML) in blast phase.
IRB Review and Approval Date: 03/06/2009
Recruitment Status: Not Accepting
Projected Accrual: N/A
1) 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;
2) Chronic myeloid leukemia in blast phase
3) Zubrod performance status </= 3;
4) 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;
5) Age >/= to 1 year
6) Understand and voluntarily sign an informed consent form.
7) For pediatric patients (age >/= 1 year to </= 18 years), Lansky performance status >/=50
8) For pediatric patients (age >/= 1 year to </= 18 years), second or greater relapse
1) Pregnant patients
2) Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.