Overview

Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage

Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborators:
Leadiant Biosciences, Inc.
Sigma Tau Pharmaceuticals, Inc.
Treatments:
Asparaginase
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Methotrexate
Pegaspargase
Rituximab
Vincristine
Criteria
Inclusion Criteria:

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
4. Adequate liver function (bilirubin renal function (creatinine
5. Age >/= to 1 year

6. Understand and voluntarily sign an informed consent form.

7. For pediatric patients (age >/= 1 year to >/=50

8. For pediatric patients (age >/= 1 year to
Exclusion Criteria:

1. Pregnant patients

2. Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic
event with PEG-l-asparaginase or its components.