Comparison · NCT03836209-66637811
Arm A vs Arm B: FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction
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. Arm A vs Arm B: FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction. Trial comparisons, record NCT03836209-66637811. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03836209-66637811
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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 | 0.367 | 0.274 | 0.47 | wilson | |
| Risk in group 2 | 0.425 | 0.327 | 0.53 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0586 | -0.198 | 0.084 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.862 | 0.598 | 1.24 | log | |
| Odds ratio, group 1 over group 2 | 0.782 | 0.428 | 1.43 | log | |
| Number needed to treat, for one fewer participant with the outcome on Arm A than on Arm B | 17.1 | from the risk difference interval | the interval includes no difference |
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 | Arm A | Induction: Daunorubicin, cytarabine and gilteritinib. Depending on response, second cycle of Induction may be given.~Consolidation: High-dose cytarabine and gilteritinib.~Gilteritinib: Induction: 120 mg orally daily x 14 days starting on day 8~Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)~Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3~Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles | 33 | 90 | OG000 |
| Group 2 | Arm B | Induction: Daunorubicin, cytarabine and midostaurin. Depending on response, second cycle of Induction may be given.~Consolidation: High-dose cytarabine and midostaurin.~Midostaurin: Induction: 50 mg orally twice daily x 14 days beginning on day 8~Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)~Daunorubicin: First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3~Cytarabine: Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles | 37 | 87 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- FLT3 Mutation Negative Complete Response (CR) Rate at End of Induction
- Description
- CR evaluated by FLT3 testing after Induction
- Time frame
- 3 months
- Population
Source ClinicalTrials.gov
Trial
- Title
- Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia
- NCT number
- NCT03836209
- Phases
- PHASE2
- Conditions
- Acute Myeloid Leukemia
- Interventions
- Gilteritinib, Midostaurin, Daunorubicin, Cytarabine
- Lead sponsor
- PrECOG, LLC.
- Results first posted
- 2025-02-28
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03836209?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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