Study of Iomab-B vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia
Summary
The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care in patients with Active, Relapsed or Refractory Acute Myeloid Leukemia (AML).
Timeline
- Start
- 2016-06
- Primary completion
- 2022-06
- Completion
- 2026-12
Outcome
Met primary endpoint
paper dCR rate was significantly higher with 131I-apamistamab (17.1% [95% CI, 9.4 to 27.5]) than conventional care (0% [95% CI, 0 to 4.7]; P < .0001). PMID 39298738 ↗
release “The SIERRA trial met its primary endpoint of durable complete remission or dCR of 6 months post initial remission after a BMT” actiniumpharma.com ↗
release “The SIERRA trial was positive with Iomab-B meeting the primary endpoint of durable Complete Remission of 6-months with high statistical significance (p<0.0001).” actiniumpharma.com ↗
release “Iomab-B achieved the primary endpoint in the SIERRA trial of durable Complete Remission (dCR) of at least 6 months with high statistical significance (p<0.0001)” actiniumpharma.com ↗
release “Iomab-B met the primary endpoint of durable Complete Remission (dCR) in the SIERRA trial with high-statistical significance (p<0.0001)” actiniumpharma.com ↗
release “The SIERRA trial met its primary endpoint of durable complete remission” actiniumpharma.com ↗
Publications
- Gyurkocza B, Nath R, Seropian S, Choe H, Litzow MR, Abboud C, Koshy N, Stiff P, Tomlinson B, Abhyankar S, Foran J, Hari P, Chen G, Al-Kadhimi Z, Kebriaei P, Sabloff M, Orozco JJ, Jamieson K, Silverman M, Van Besien K, Schuster M, Law AD, Larkin K, Pandit-Taskar N, Rowley SD, Munshi P, Cook R, Levy MY, Lazarus HM, Sandmaier BM, Pagel JM, Reddy V, MacDougall J, McNamara K, Spross J, Haeuber E, Vusirikala M, Nahar A, Desai A, Giralt S. Randomized Phase III SIERRA Trial of 131I-Apamistamab Before Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care for Relapsed/Refractory AML. J Clin Oncol. 2025 Jan 10;43(2):201-213. doi: 10.1200/JCO.23.02018. Epub 2024 Sep 19.
- Walter RB. Where do we stand with radioimmunotherapy for acute myeloid leukemia? Expert Opin Biol Ther. 2022 May;22(5):555-561. doi: 10.1080/14712598.2022.2060735. Epub 2022 Mar 31.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Azacitidine | Other / unclassified | — | — |
| Comparator | Carboplatin | Small molecule | — | — |
| Comparator | Cladribine | Small molecule | — | — |
| Comparator | Clofarabine | Other / unclassified | — | — |
| Comparator | Cyclophosphamide | Other / unclassified | — | — |
| Comparator | Cytarabine | Small molecule | — | — |
| Comparator | Daunorubicin | Small molecule | — | — |
| Comparator | Decitabine | Small molecule | — | — |
| Comparator | Doxorubicin | Other / unclassified | — | — |
| Comparator | Enasidenib | Small molecule | — | — |
| Comparator | Etoposide | Small molecule | — | — |
| Comparator | Fludarabine | Small molecule | — | — |
| Comparator | Gemtuzumab Ozogamicin | Monoclonal antibody | — | — |
| Subject | IODINE I 131 APAMISTAMAB | Monoclonal antibody | — | — |
| Comparator | Idarubicin | Small molecule | — | — |
| Comparator | Ivosidenib | Small molecule | — | — |
| Comparator | L-asparaginase | Protein / enzyme biologic | — | — |
| Comparator | Midostaurin | Small molecule | — | — |
| Comparator | Mitoxantrone | Small molecule | — | — |
| Comparator | Sorafenib | Small molecule | — | — |
| Comparator | Thioguanine | Small molecule | — | — |
| Comparator | Topotecan | Small molecule | — | — |
| Comparator | Venetoclax | Small molecule | — | — |