Phase 3 N=5,377 Randomized Treatment

Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia

Acute Lymphoblastic Leukemia · Childhood B Acute Lymphoblastic Leukemia

Bottom Line

View on ClinicalTrials.gov: NCT00103285 ↗

Enrolled (actual)

5,377

Serious AEs

1.3%

Results posted

Jul 2018

Primary outcome: Primary: Event-free Survival (EFS) for SR-Average ALL Patients — 83.82; 88.89; 88.34; 90.51 percent probability

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: 3-Dimensional Conformal Radiation Therapy (Radiation); Cyclophosphamide (Drug); Cytarabine (Drug); Dexamethasone (Drug); Doxorubicin Hydrochloride (Drug); Leucovorin Calcium (Drug); Mercaptopurine (Drug); Methotrexate (Drug); Pegaspargase (Drug); Thioguanine (Drug); Vincristine Sulfate (Drug)
Age: Pediatric · 1+ yrs
Sex: All
Sponsor: Children's Oncology Group
Primary completion: Dec 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Event-free Survival (EFS) for SR-Average ALL Patients	83.82; 88.89; 88.34; 90.51; 87.41; 88.29	—
PRIMARY Event-free Survival (EFS) for SR-Low Patients	95.22; 93.96	—
SECONDARY Health-related Quality of Life Relative to Physical, Social and Emotional Impairment	76.39; 42.75; 29.41; 27.84; 43.36; 23.66	—
SECONDARY Event-Free Survival Probability According to MRD Status End Induction (Day 29)	91.39; 79.86	—
SECONDARY Overall Survival Probability (OS) According to Induction Day 29 MRD Status	97.07; 90.47	—
SECONDARY Early Marrow Status (EMS) by MRD Status End Induction (Day 29)	4378; 258	—
SECONDARY Optimal Time Point for Advance Health Related Quality of Life Intervention	25.2; 24.0	—
SECONDARY Event-free Survival (EFS) for SR-High Patients.	85.58	—
SECONDARY Event-Free Survival (EFS) for Low MRD (Negative) Subjects by Genetic Subset (TEL/Trisomy Positive vs Negative)	95.22; 88.52	—

Summary

This randomized phase III trial is studying different combination chemotherapy regimens and comparing how well they work in treating patients with newly diagnosed acute lymphoblastic leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

Eligibility Criteria

Inclusion Criteria

Patients must be enrolled on AALL03B1 prior to enrollment on AALL0331
Initial white blood cells (WBC) = 2 years (note that this is a more restrictive age range than for the therapeutic component of the study)
At least one parent with reading comprehension of English or Spanish languages for which validated surveys exist
Diagnosis at one of the institutions participating in this limited institution correlative study
A parent or legal guardian must sign a written informed consent/parental permission for all patients
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00103285). 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.