Table 4.
Clinical trials of RIT for AML.
| NCI Clinical Trial and Phase | Target | Agent(s) | Inclusion Criteria | Estimated Start and End Dates | Outcomes | Status |
|---|---|---|---|---|---|---|
|
NCT02665065
(SIERRA) Phase 3 |
CD45 | 131I-BC8 Fludarabine 2-Gy TBI | ≥55 years of age with R/R AML patients | June 2015 June 2020 |
Durable CR and OS at 1 year | Recruiting |
|
NCT03867682 Phase 1/2 |
CD33 | 225Ac-lintuzumab Venetoclax Spironolactone | ≥18 years of age with refractory R/R AML. | May 2019 November 2022 |
MTD and complete and partial remission status at 6, 12, and 24 months | Not yet recruiting |
|
NCT03670966 Phase 1/2 |
CD45 | 211At-BC8 Fludarabine Cyclophosphamide 2-Gy TBI Haplotype transplant | ≥18 years of age with R/RAML who have an available haploindentical donor for a haplo HSCT. | March 2019 September 2024 |
Toxicity (GVHD, and NRM), donor chimerism, rate of engraftment, and OS up to 100 days and maintenance of remission at 2 years | Recruiting |
|
NCT03128034 Phase 1/2 |
CD45 | 211At-BC8 Fludarabine 2-3-Gy TBI Haplotype transplant | ≥18 years of age with R/R AML who have an available haploindentical donor for a haplo HSCT. | October 2017 March 2023 |
Toxicity (GVHD, and NRM), donor chimerism, rate of engraftment, and OS up to 100, remission at 2 years | Recruiting |
|
NCT03441048 Phase 1 |
CD45 | 211At-BC8 CLAG-M (cladribine, cytarabine, G-CSF, mitoxantrone) | ≥18 years of age with R/R AML | May 2018 October 2020 |
MTD and toxicity | Recruiting |
AML: acute myeloid leukemia; R/R: relapsed/refractory; MTD: maximum tolerated dose; OS: overall survival; GVHD: graft versus host disease; NRM: non-relapse mortality.