Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 37
- Locations
- 1
- Primary Endpoint
- Complete Response (CR) Rate
Study Overview
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 ALL that has not responded to previous treatment or has come back after a response or chronic myeloid leukemia (CML).
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 multiplication of cancer cells, which may slow or stop their growth and spread throughout the body. This may cause the cancer cells to die.
Pegylated-L-asparaginase is designed to get rid of an important building block of proteins in leukemia cells.
Dexamethasone is a steroid that causes the leukemia cells to breakdown.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •Pregnant patients
- •Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
Arms & Interventions
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Intervention: PEG-l-asparaginase (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Intervention: Dexamethasone (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Intervention: Methotrexate (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Intervention: Vincristine (Drug)
MOAD
Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
Intervention: Rituximab (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported