{"id":1290,"date":"2018-09-14T15:56:00","date_gmt":"2018-09-14T13:56:00","guid":{"rendered":"https:\/\/lensounds.com\/science\/211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome\/"},"modified":"2018-09-14T15:56:00","modified_gmt":"2018-09-14T13:56:00","slug":"211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome","status":"publish","type":"science","link":"https:\/\/atonco-pharma.com\/en\/science\/211at-bc8-b10-followed-by-donor-stem-cell-transplant-in-treating-patients-with-relapsed-or-refractory-high-risk-acute-leukemia-or-myelodysplastic-syndrome\/","title":{"rendered":"211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome"},"content":{"rendered":"<h2>Abstract<\/h2>\n<p>This Phase I\/II dose-escalation trial evaluates <sup>211<\/sup>At-BC8-B10 (an anti-CD45 \u03b1-particle\u2013emitting monoclonal antibody) as a conditioning agent before haploidentical hematopoietic cell transplantation (HCT) for patients with relapsed or refractory high-risk acute leukemias and myelodysplastic syndromes (MDS). Eligible patients include those with AML, ALL, MPAL, or high-risk MDS (age 18\u201375 years). The preparative regimen consists of <sup>211<\/sup>At-BC8-B10 (Day -8, dose-escalation), fludarabine (Days -6 to -2), cyclophosphamide (Days -6, -5), and total-body irradiation (Day -1), followed by PBSC or bone marrow infusion (Day 0). GVHD prophylaxis includes post-transplant cyclophosphamide (Days 3-4), mycophenolate mofetil (Days 5-35), and tacrolimus (Days 5-180). The primary endpoint is grades III\/IV regimen-related toxicity to determine maximum tolerated dose. Secondary endpoints include remission achievement, engraftment rates, donor chimerism, non-relapse mortality, GVHD incidence, and overall\/disease-free survival at 2 years. This approach combines the superior cytotoxic properties of \u03b1-particle therapy with haploidentical HCT&#8217;s immunologic advantages and PTCy-based GVHD prevention, offering the potential to improve outcomes in this patient population with otherwise poor prognosis.<\/p>\n<h2>Publication Information<\/h2>\n<p><strong>Source:<\/strong> ClinicalTrials.gov<\/p>\n<p><strong>Trial Registration Date:<\/strong> September 14, 2018<\/p>\n<p><strong>Last Update Posted:<\/strong> October 16, 2025<\/p>\n<p><strong>Trial ID:<\/strong> NCT03670966<\/p>\n<p><strong>ClinicalTrials.gov Link:<\/strong> <a href=\"https:\/\/clinicaltrials.gov\/study\/NCT03670966\" target=\"_blank\" rel=\"noopener\">https:\/\/clinicaltrials.gov\/study\/NCT03670966<\/a><\/p>\n<h2>Authors<\/h2>\n<p><strong>Sponsor:<\/strong> Fred Hutchinson Cancer Center<\/p>\n<p><strong>Principal Investigator:<\/strong> Phuong Vo, MD<\/p>\n<p><strong>Contact:<\/strong> Phone: 206-667-2749; Email: ptvo@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> 30 patients<\/p>\n<p><strong>Study Timeline:<\/strong> July 10, 2019 \u2013 March 20, 2029 (estimated)<\/p>\n<p><strong>Funding:<\/strong> National Cancer Institute (NCI); NIH Grants P30CA015704 and P01CA078902<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ClinicalTrials.gov ID: NCT03670966 &#8211; Sponsor: Fred Hutchinson Cancer Center &#8211; ClinicalTrials.gov Link: https:\/\/clinicaltrials.gov\/study\/NCT03670966<\/p>\n","protected":false},"featured_media":0,"template":"","meta":[],"science_category":[49],"class_list":["post-1290","science","type-science","status-publish","hentry","science_category-at-211-publications"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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