Comparison · NCT00103285-d9773fa7
All Patients for Induction, MRD Negative vs All Patients for Induction, MRD Positive: Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. All Patients for Induction, MRD Negative vs All Patients for Induction, MRD Positive: Early Marrow Status (EMS) by MRD Status End Induction (Day 29). Trial comparisons, record NCT00103285-d9773fa7. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00103285-d9773fa7
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.95 | 0.943 | 0.956 | wilson | |
| Risk in group 2 | 0.713 | 0.664 | 0.757 | wilson | |
| Risk difference, group 1 minus group 2 | 0.237 | 0.192 | 0.286 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.33 | 1.25 | 1.42 | log | |
| Odds ratio, group 1 over group 2 | 7.64 | 5.87 | 9.94 | log | |
| Number needed to treat, for one more participant with the outcome on All Patients for Induction, MRD Negative than on All Patients for Induction, MRD Positive | 4.22 | 3.49 | 5.2 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | All Patients for Induction, MRD Negative | All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV | 4,378 | 4,609 | OG000 |
| Group 2 | All Patients for Induction, MRD Positive | All patients receive cytarabine intrathecally (IT) on day 1; vincristine IV on days 1, 8, 15, and 22; dexamethasone IV or orally (PO) twice daily (BID) on days 1-28; pegaspargase intramuscularly (IM) (may give IV over 1 to 2 hours) on day 4, 5, or 6; and methotrexate IT on days 8 and 29 (and days 15 and 22 for patients with CNS3 disease). Patients with Down syndrome (DS) receive leucovorin calcium PO at 48 and 60 hours after each dose of methotrexate IT. Patients are assessed for response on day 29. Patients with M1 bone marrow AND minimal residual disease (MRD) \< 0.1% OR MRD \>= 0.1% and \< 1% proceed to therapy in part II. Patients with M2 bone marrow OR M1 bone marrow AND MRD \>= 1% proceed to extended induction therapy. Patients with M3 bone marrow are removed from the study.~cytarabine: Given IV or SC~dexamethasone: Given IV or PO~pegaspargase: Given IM~methotrexate: Given IM or IT~vincristine sulfate: Given IV | 258 | 362 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Early Marrow Status (EMS) by MRD Status End Induction (Day 29)
- Description
- Early Marrow Status defined as M1 versus M2/M3 marrow is correlated with MRD (Positive vs. Negative)
- Time frame
- Early Marrow Status at Day 15, MRD Status at Day 29 of therapy.
- Population
Patients who had MRD day 29 data but their Bone Marrow (BM) days 8/15 data were missing are excluded. This analysis was done with patients who had both MRD and BM data. There were 5 patients excluded in both MRD Negative and MRD Positive groups due to missing days 8/15 BM.
Source ClinicalTrials.gov
Trial
- Title
- Combination Chemotherapy in Treating Young Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
- NCT number
- NCT00103285
- Phases
- PHASE3
- Conditions
- Acute Lymphoblastic Leukemia, Childhood B Acute Lymphoblastic Leukemia
- Interventions
3-Dimensional Conformal Radiation Therapy, Cyclophosphamide, Cytarabine, Dexamethasone, Doxorubicin Hydrochloride, Leucovorin Calcium, Mercaptopurine, Methotrexate, Pegaspargase, Thioguanine, Vincristine Sulfate
- Lead sponsor
- Children's Oncology Group
- Results first posted
- 2018-07-11
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00103285?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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