Phase 3
Completed N=5,377
Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Source: ClinicalTrials.gov NCT00103285 ↗Enrolled (actual)
5,377
Serious AEs
1.3%
Results posted
Jul 2018
Primary outcomePrimary: Event-free Survival (EFS) for SR-Average ALL Patients — 83.82; 88.89; 88.34; 90.51 percent probability
◆ Published Evidence
Highly cited
227citations · ~28 / year
Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL.
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.
Linked Publications (5)
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Measurable residual disease detection by high-throughput sequencing improves risk stratification for pediatric B-ALL.
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Genomic Determinants of Outcome in Acute Lymphoblastic Leukemia.
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Outcomes in Children, Adolescents, and Young Adults With Down Syndrome and ALL: A Report From the Children's Oncology Group.
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Germ line genetic NBN variation and predisposition to B-cell acute lymphoblastic leukemia in children.
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Performance of Two-Phase Designs for the Time-to-Event Outcome and a Case Study Assessing the Relapse Risk Associated With B-ALL Subtypes.
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 | — |
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
Data sourced from ClinicalTrials.gov (NCT00103285) and the linked publication. 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.