ITCC-059
A phase 1 study of inotuzumab ozogamicin in pediatric relapsed/refractory acute lymphoblastic leukemia (ITCC-059 study)
Phase 1N = 25
- Population
- Pediatric patients (age 1 year or older and under 18 years) with multiple relapsed or refractory CD22-positive ALL
- Design
- Phase 1 dose-escalation study of inotuzumab ozogamicin, a CD22-directed antibody-drug conjugate, given as 3 doses (days 1, 8 and 15) per course; dose level 1 was 1.4 mg/m2 and dose level 2 was 1.8 mg/m2 per course. 25 patients were enrolled (23 evaluable for dose-limiting toxicities). Registered as EudraCT 2016-000227-71; no ClinicalTrials.gov number found. The FDA label for inotuzumab ozogamicin reports a 53-patient pediatric analysis of this study (Pfizer study WI203581, described there as ITCC-059), a larger data set than the 25 patients of the published phase 1 report.
- Arms
- Inotuzumab ozogamicin (experimental, n = 25): 3 doses per course on days 1, 8 and 15; dose level 1 1.4 mg/m2 (0.6, 0.4, 0.4 mg/m2), dose level 2 1.8 mg/m2 (0.8, 0.5, 0.5 mg/m2); recommended phase 2 dose 1.8 mg/m2 per course
- People
- Brivio E, senior author Zwaan CM
Show the numbers
| Endpoint | Analysis | Inotuzumab ozogamicin | Control | Effect |
|---|---|---|---|---|
| Overall remission rateEnrolled patients (25)Overall response rate after course 1, as named in the abstract (definition not given in the abstract) | primaryBrivio 2021 | 80% (59–93%) | — | 20 of 25 patients. Dose level 1: 75% (95% CI 43 to 95); dose level 2: 85% (95% CI 55 to 98). |
| MRD-negative remission rateResponders after course 1 (20)Minimal residual disease-negative complete response among responders | primaryBrivio 2021 | 84% (60–97%) | — | — |
| OSEnrolled patients (25) | primaryBrivio 2021 | 40% at 12 mo (25–66%) | — | Interval as published; it is asymmetric around the point estimate. |
| Endpoint | Analysis | Inotuzumab ozogamicin | Control | Effect |
|---|---|---|---|---|
| Overall remission rateEnrolled patients (25)Overall response rate after course 1, as named in the abstract (definition not given in the abstract) | primaryBrivio 2021 | 80% (59–93%) | — | 20 of 25 patients. Dose level 1: 75% (95% CI 43 to 95); dose level 2: 85% (95% CI 55 to 98). |
| MRD-negative remission rateResponders after course 1 (20)Minimal residual disease-negative complete response among responders | primaryBrivio 2021 | 84% (60–97%) | — | — |
| OSEnrolled patients (25) | primaryBrivio 2021 | 40% at 12 mo (25–66%) | — | Interval as published; it is asymmetric around the point estimate. |