Clinical trial · Interventional
Methotrexate, Vincristine, Pegylated L-Asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
Phase II Study of Methotrexate, Vincristine, Pegylated L-asparaginase and Dexamethasone (MOAD) in Acute Lymphoblastic Leukemia (ALL) Salvage
NCT00905034CI-TRIAL-00018395completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, Lymphocytic, Acute | Leukemia | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| PEG-l-asparaginase | Drug | — | UNRESOLVED |
| Rituximab | Drug | Rituximab | ALIAS |
| Vincristine | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MOAD
- description
- Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD).
- interventionNames
- Drug: Methotrexate
- Drug: Vincristine
- Drug: PEG-l-asparaginase
- Drug: Dexamethasone
- Drug: Rituximab
Primary outcomes (1)
- measure
- Complete Response (CR) Rate
- timeFrame
- 6 cycles (cycle = 28 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
Show eligibility criteria text
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 \</= 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 Exclusion Criteria: 1. Pregnant patients 2. Prior history of allergic reaction, serious pancreatitis, hemorrhagic or thrombotic event with PEG-l-asparaginase or its components.
References
Publications (0)
Data not yet available
No reference posted for this study.