Phase 3
Completed N=498
Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia
Lymphoblastic Leukemia, Acute
Source: ClinicalTrials.gov NCT00137111 ↗
Enrolled (actual)
498
Serious AEs
14.9%
Results posted
Apr 2011
Primary outcomePrimary: Overall Event-free Survival (EFS) — 87.3 Percentage of Participants
Summary
The primary objective is to estimate the overall event-free survival of children at least one year of age at diagnosis who are treated with risk-directed therapy and to monitor the molecular remission induction rate.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Event-free Survival (EFS) |
87.3 | — |
| PRIMARY Continuous Complete Remission Since Week 56 Therapy. |
92.2 | — |
| SECONDARY Minimal Residual Disease (MRD) |
390; 102 | — |
| SECONDARY Mean Difference of Active Methotrexate Polyglutamates (MTXPG) in Leukemia Cells Between Two Arms (4 Hours vs. 24 Hours). |
1688; 2521 | .0062 sig |
| SECONDARY Circulating Leukemia Cells in Peripheral Blood Change From Prior to the Methotrexate Infusion to Three Days After Between Two Arms (4 Hours vs. 24 Hours) |
-44; -50 | .15 |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of non-B-cell ALL by immunophenotyping, as determined by the reactivity pattern to a panel of monoclonal antibodies with flow cytometry as well as morphology and cytochemical staining.
- Age range: 1 to 18 years (inclusive).
Exclusion Criteria
- Previously treated with chemotherapy for one week or longer.
Data sourced from ClinicalTrials.gov (NCT00137111). 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. Informational only — not medical advice.