Comparison · NCT03817320-099ffb0e
Ixazomib Dose Level 1 (Stratum A) vs Ixazomib Dose Level 2 (Stratum A): Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
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ConductScience Library. Ixazomib Dose Level 1 (Stratum A) vs Ixazomib Dose Level 2 (Stratum A): Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy. Trial comparisons, record NCT03817320-099ffb0e. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03817320-099ffb0e
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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 | 0.0000000000000000555 | 0.561 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.39 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.39 | 0.561 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to treat | from the risk difference interval | the two groups' risks are equal |
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 | Ixazomib Dose Level 1 (Stratum A) | Block 1 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.~Block 2 - Patients will be treated on ixazomib at 1.6 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled. | 0 | 3 | OG000 |
| Group 2 | Ixazomib Dose Level 2 (Stratum A) | Block 1 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, and 11. Vincristine IV at 1.5 mg/m\^2 on Days 1, 8, 15 and 22. Pegaspargase IV/IM at 2500 IU/m\^2 on Days 2 and 15 OR Calaspargase IV 2500 IU/m\^2 on Day 2. Doxorubicin at 60 mg/m\^2 on Days 1. Leucovorin IV/PO at 5 mg/m\^2 at hour 24 and 30 post-ITs. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 14.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled.~Block 2 - Patients will be treated on ixazomib at 2 mg/m\^2/day on Days 1, 4, 8, 15, and 18. Vincristine IV at 1.5 mg/m\^2 on Day 3. Pegaspargase IV/IM at 2500 IU/m\^2 OR Calaspargase IV 2500 IU/m\^2 on Day 9. Methotrexate IV 1000 mg/m\^2 on Day 8. Dexamethasone IV/PO at 10 mg/m\^2 continuous starting on Day 1 thru Day 8.and IT chemotherapy dependent on patient's CNS status at time of enrollment. This arm is the starting Dose Level for patients being enrolled. | 0 | 6 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Phase 1: Dose Limiting Toxicity (DLT) During Block 1 of Chemotherapy
- Description
- The incidence of dose limiting toxicity (DLT) will be measured only during block 1
- Time frame
- 5 weeks
- Population
Patients with Down Syndrome enrolled in Ixazomib Dose Level 1 (Stratum B) are not eligible for inclusion in the primary DLT or response evaluation. Only the first 6 patients enrolled in Dose Level 2 Stratum A were part of the Phase I portion of this study.
Source ClinicalTrials.gov
Trial
- Title
- PO Ixazomib in Combination With Chemotherapy for Childhood Relapsed or Refractory Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma
- NCT number
- NCT03817320
- Phases
- PHASE1, PHASE2
- Conditions
- ALL, Childhood, Lymphoblastic Lymphoma, Childhood, Lymphoblastic Leukemia, Acute, Childhood
- Interventions
- Ixazomib, Vincristine, Dexamethasone, Asparaginase, Doxorubicin, Methotrexate (IT), Triple IT (Methotrexate, Hydrocortisone, Cytarabine), Leucovorin
- Lead sponsor
- Therapeutic Advances in Childhood Leukemia Consortium
- Results first posted
- 2025-06-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03817320?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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