Comparison · NCT04501614-63b3f76a
Ponatinib 30 mg Adult-Equivalent vs Ponatinib 15 mg Adult-Equivalent: Phase 1: Number of Participants With CR at the End of Reinduction Block
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. Ponatinib 30 mg Adult-Equivalent vs Ponatinib 15 mg Adult-Equivalent: Phase 1: Number of Participants With CR at the End of Reinduction Block. Trial comparisons, record NCT04501614-63b3f76a. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04501614-63b3f76a
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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 | 0.167 | 0.0301 | 0.564 | wilson | |
| Risk in group 2 | 0.667 | 0.208 | 0.939 | wilson | |
| Risk difference, group 1 minus group 2 | -0.5 | -0.804 | 0.107 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.25 | 0.0352 | 1.77 | log | |
| Odds ratio, group 1 over group 2 | 0.1 | 0.00399 | 2.5 | log | |
| Number needed to treat, for one fewer participant with the outcome on Ponatinib 30 mg Adult-Equivalent than on Ponatinib 15 mg Adult-Equivalent | 2 | 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 | Ponatinib 30 mg Adult-Equivalent | Participants received weight-based dose of ponatinib tablets 30 mg adult-equivalent, orally, once daily in combination with chemotherapy backbone per standard regimen at the investigator's discretion in both reinduction block and consolidation block (35 days each including 29 days of treatment in combination with chemotherapy followed by a minimum 6-day rest period from chemotherapy with daily ponatinib only) up to Day 70 (end of consolidation) followed by optional ponatinib continuation in Phase 1. | 1 | 6 | OG000 |
| Group 2 | Ponatinib 15 mg Adult-Equivalent | Participants received weight-based dose of ponatinib tablets 15 mg adult-equivalent, orally, once daily in combination with chemotherapy backbone per standard regimen at the investigator's discretion in both reinduction block and consolidation block (35 days each including 29 days of treatment in combination with chemotherapy followed by a minimum 6-day rest period from chemotherapy with daily ponatinib only) up to Day 70 (end of consolidation) followed by optional ponatinib continuation in Phase 1. | 2 | 3 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Phase 1: Number of Participants With CR at the End of Reinduction Block
- Description
CR was defined as no circulating blasts and \<5% blasts in the BM; normal maturation of all cellular components in the bone marrow; no extramedullary disease; ANC \>1000 cells/μL (or \>1.0 × 10\^9 cells/L); Platelets \>100,000/μL (or \>100 × 10\^9 platelets/L).
- Time frame
- Day 35 in Phase 1
- Population
- The Safety Population included all participants who received at least 1 dose of ponatinib. Overall number of participants analyzed is the number of participants with data available for analysis.
Source ClinicalTrials.gov
Trial
- Title
- A Study of Ponatinib With Chemotherapy in Children, Teenagers, and Adults With Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
- NCT number
- NCT04501614
- Phases
- PHASE1, PHASE2
- Conditions
- Pediatric Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ALL), Ph+ Mixed Phenotype Acute Leukemia (MPAL), Philadelphia Chromosome-Like ALL (Ph-like ALL)
- Interventions
- Ponatinib, Chemotherapy Agents
- Lead sponsor
- Takeda
- Results first posted
- 2025-01-15
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04501614?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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