Phase 2
N=37
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Leukemia, Lymphocytic, Acute
Bottom Line
View on ClinicalTrials.gov: NCT00905034 ↗Enrolled (actual)
37
Serious AEs
89.2%
Results posted
Jun 2015
Primary outcome: Primary: Complete Response (CR) Rate — 28 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Methotrexate (Drug); Vincristine (Drug); PEG-l-asparaginase (Drug); Dexamethasone (Drug); Rituximab (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Feb 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
28 | — |
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).
Eligibility Criteria
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 /= to 1 year
- Understand and voluntarily sign an informed consent form.
- For pediatric patients (age >/= 1 year to /=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.
Data sourced from ClinicalTrials.gov (NCT00905034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.