{"id":1289,"date":"2017-04-25T15:52:00","date_gmt":"2017-04-25T13:52:00","guid":{"rendered":"https:\/\/lensounds.com\/science\/211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia\/"},"modified":"2026-03-06T18:37:48","modified_gmt":"2026-03-06T17:37:48","slug":"211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia","status":"publish","type":"science","link":"https:\/\/atonco-pharma.com\/en\/science\/211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia\/","title":{"rendered":"211At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia"},"content":{"rendered":"<h2>Abstract<\/h2>\n<p>This Phase I\/II dose-escalation trial evaluates escalating doses of \u00b2\u00b9\u00b9At-BC8-B10 (astatine-211 labeled anti-CD45 monoclonal antibody BC8) administered before allogeneic hematopoietic cell transplantation (HCT) in patients with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), or mixed-phenotype acute leukemia (MPAL). The study aims to determine the maximum tolerated dose (MTD) of \u00b2\u00b9\u00b9At-BC8-B10 when combined with reduced-intensity conditioning, with primary endpoint of regimen-related toxicity grades III\/IV assessed up to 100 days post-transplant. Secondary endpoints include engraftment, chimerism, non-relapse mortality, acute GVHD, remission achievement, and overall\/disease-free survival up to 2 years. Estimated enrollment of 75 patients with primary completion in June 2027. This trial represents a landmark investigation of alpha-particle therapy in allogeneic HCT for high-risk hematologic malignancies, leveraging the superior cytotoxic properties of alpha particles and CD45-targeting specificity to improve outcomes in patients with refractory disease, measurable residual disease, or relapsed leukemia.<\/p>\n<h2>Publication Information<\/h2>\n<p><strong>Source:<\/strong> ClinicalTrials.gov<\/p>\n<p><strong>Trial Registration Date:<\/strong> April 25, 2017<\/p>\n<p><strong>Last Update Posted:<\/strong> June 18, 2025<\/p>\n<p><strong>Trial ID:<\/strong> NCT03128034<\/p>\n<p><strong>ClinicalTrials.gov Link:<\/strong> <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03128034\" target=\"_blank\" rel=\"noopener\">https:\/\/clinicaltrials.gov\/study\/NCT03128034<\/a><\/p>\n<h2>Authors<\/h2>\n<p><strong>Sponsor:<\/strong> Fred Hutchinson Cancer Center<\/p>\n<p><strong>Principal Investigator:<\/strong> Brenda M. Sandmaier, MD<\/p>\n<p><strong>Contact:<\/strong> Phone: 206-667-4961; Email: bsandmai@fredhutch.org<\/p>\n<p><strong>Institutional Affiliation:<\/strong> Fred Hutch\/University of Washington Cancer Consortium, Seattle, Washington, United States<\/p>\n<p><strong>Phase:<\/strong> Phase I\/II<\/p>\n<p><strong>Estimated Enrollment:<\/strong> 75 patients<\/p>\n<p><strong>Study Timeline:<\/strong> October 24, 2017 \u2013 March 31, 2029 (estimated)<\/p>\n<p><strong>Funding:<\/strong> National Cancer Institute (NCI); NIH Grant P01CA078902; Fred Hutch\/University of Washington Cancer Consortium<\/p>\n<p><strong>Key Publications:<\/strong> Li Y, Hamlin DK, Chyan MK, et al. cGMP production of astatine-211-labeled anti-CD45 antibodies for use in allogeneic hematopoietic cell transplantation. PLoS One. 2018;13(10):e0205135.<\/p>\n","protected":false},"excerpt":{"rendered":"<p> ClinicalTrials.gov ID: NCT03128034 &#8211; Sponsor: Fred Hutchinson Cancer Center &#8211; ClinicalTrials.gov Link: https:\/\/clinicaltrials.gov\/study\/NCT03128034<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"science_category":[49],"class_list":["post-1289","science","type-science","status-publish","hentry","science_category-at-211-publications"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>211At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia - Atonco<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/atonco-pharma.com\/en\/science\/211at-bc8-b10-before-donor-stem-cell-transplant-in-treating-patients-with-high-risk-acute-myeloid-leukemia-acute-lymphoblastic-leukemia-myelodysplastic-syndrome-or-mixed-phenotype-acute-leukemia\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"211At-BC8-B10 Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, Myelodysplastic Syndrome, or Mixed-Phenotype Acute Leukemia - 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