Phase 3 N=498 Randomized Treatment

Therapy for Newly Diagnosed Patients With Acute Lymphoblastic Leukemia

Lymphoblastic Leukemia, Acute

Bottom Line

View on ClinicalTrials.gov: NCT00137111 ↗

Enrolled (actual)

498

Serious AEs

14.9%

Results posted

Apr 2011

Primary outcome: Primary: Overall Event-free Survival (EFS) — 87.3 Percentage of Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Prednisone, Dexamethasone, Vincristine, Daunorubicin (Drug); Doxorubicin, L-asparaginase, PEG-L-asparaginase, Erwinia asparaginase (Drug); Methotrexate, Cyclophosphamide, Cytarabine, Etoposide (Drug); Mercaptopurine, Imatinib (Drug); chemotherapy, intrathecal chemotherapy (Procedure); steroid therapy, hematopoietic stem cell transplantation (Procedure)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: St. Jude Children's Research Hospital
Primary completion: Nov 2010

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

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.

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.

View full record on ClinicalTrials.gov →

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.