NCT03128034

211^At-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

A Study Evaluating Escalating Doses of 211^At-Labeled Anti-CD45 MAb BC8-B10 (211^At-BC8-B10) Followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 75 (estimated)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This phase I/II trial studies the side effects and best dose of 211\^astatine(At)-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. Radioactive substances, such as astatine-211, linked to monoclonal antibodies, such as BC8, can bind to cancer cells and give off radiation which may help kill cancer cells and have less of an effect on healthy cells before donor stem cell transplant.

Detailed description

OUTLINE: This is a dose-escalation study of 211\^At-BC8-B10. Patients receive 211\^At-BC8-B10 intravenously (IV) over 6-8 hours on day -7 and may receive 131\^I-BC8-B10 IV on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and peripheral blood stem cell (PBSC) transplant on day 0. Patients also receive cyclosporine orally (PO) or IV every 12 hours on days -3 to 56 and then tapered to day 180 (for patients with related donors), or continuing to day 96 and then tapered to day 150 (for patients with unrelated donors). Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors). Patients may undergo single photon emission computed tomography (SPECT), bone marrow aspirate sample and blood sample collection on study. After completion of study treatment, patients are followed up at 100 days and then at 6, 9, 12, 18 and 24 months.

Conditions

• Acute Lymphoblastic Leukemia
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Acute Myeloid Leukemia
• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndrome With Excess Blasts
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Mixed Phenotype Acute Leukemia
• Refractory Acute Myeloid Leukemia
• Refractory Mixed Phenotype Acute Leukemia
• Mixed Phenotype Acute Leukemia

Interventions

Type	Name	Description
DRUG	Cyclosporine	Given PO or IV
DRUG	Fludarabine Phosphate	Given IV
DRUG	Mycophenolate Mofetil	Given PO or IV
PROCEDURE	Peripheral Blood Stem Cell Transplantation	Undergo allogeneic PBSC transplant
RADIATION	Pretargeted Radioimmunotherapy	Given 211\^At-BC8-B10 IV
RADIATION	Total-Body Irradiation	Undergo TBI
RADIATION	Pretargeted Radioimmunotherapy	Given 131\^I-BC8-B10 IV
PROCEDURE	Biospecimen Collection	Undergo blood and bone marrow aspirate sample collection
PROCEDURE	Single Photon Emission Computed Tomography	Undergo SPECT

Timeline

• Start date: 2017-10-24
• Primary completion: 2027-06-30
• Completion: 2029-03-31
• First posted: 2017-04-25
• Last updated: 2025-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study