211^At-BC8-B10 Before Donor Stem Cell Transplant for High-Risk Leukemias and Myelodysplastic Syndrome
This study is looking at the side effects and best dose of a treatment called 211^At-BC8-B10 when given before a donor stem cell transplant. This treatment uses a radioactive substance (astatine-211) attached to a special protein (BC8) that aims to target and kill cancer cells while having less effect on healthy cells. It's for patients aged 18-75 with high-risk acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), or mixed-phenotype acute leukemia (MPAL). The main goal is to see how many patients experience serious side effects within 30 days after the transplant. The study plans to enroll 75 patients, but its current recruitment status is unclear.
- Study design
- This is a dose-escalation study, meaning participants will receive increasing doses of 211^At-BC8-B10 to find the safest and most effective amount. It plans to enroll 75 participants.
- What's involved
- You would receive 211^At-BC8-B10 and potentially 131^I-BC8-B10 intravenously, along with fludarabine phosphate, total body irradiation, and a stem cell transplant. You would also take cyclosporine and mycophenolate mofetil for several months.
- Compensation
- Not stated in the trial record.
- Follow-up
- After treatment, you will have follow-up visits at 100 days, and then at 6, 9, 12, 18, and 24 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
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
Recruiting
PHASE1Ages 18–75InterventionalTreatmentFred Hutchinson Cancer CenterInvestigator-initiated
~75 participants
Updated 2026-06-22 on ClinicalTrials.gov
What's tested:CyclosporineFludarabine PhosphateMycophenolate MofetilPeripheral Blood Stem Cell TransplantationPretargeted RadioimmunotherapyTotal-Body Irradiation
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of dose limiting toxicity (DLT)
Measured over Up to 30 days post-transplant, with a review period for occurrence of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) extended to 60 days post-transplant
Conditions
Where it's being run
1 sites across 1 statesWashington1
Study leadership
- Brenda M. Sandmaier · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Patients must have AML, ALL, high-risk MDS, or MPAL (also known as biphenotypic) meeting one of the following descriptions:
AML, ALL, or MPAL in first remission with evidence of measurable residual disease (MRD) by flow cytometry
AML, ALL, or MPAL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)
AML, ALL, or MPAL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)
AML evolved from myelodysplastic or myeloproliferative syndromes
MDS expressed as refractory anemia with excess blasts (RAEB)
Chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria
Patients not in remission must have CD45-expressing leukemic blasts. Patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up \>= 95% of nucleated cells in the marrow)
Patients must be \>= 18 and =\< 75 years of age
Patients should have a circulating blast count of less than 10,000/mm\^3 (control with hydroxyurea or similar agent is allowed)
Patients must have an estimated creatinine clearance greater than 50/ml per minute by the following formula (Cockcroft-Gault); serum creatinine value must be within 28 days prior to registration
Patients must have normal hepatic function (bilirubin within normal limits, aspartate aminotransferase \[AST\] and alanine aminotransferase \[ALT\] \< 2 times the upper limit of normal) within 2 months prior to the astatine-211 infusion date (with the exception of patients that are known to have Gilbert's disease, for whom total bilirubin is allowed up to 3 x upper limit of normal \[ULN\])
Eastern Cooperative Oncology Group (ECOG) \< 2 or Karnofsky \>= 70
Patients must be free of uncontrolled infection
Patients with prior non-myeloablative or reduced-intensity conditioning allogeneic-hematopoietic cell transplant (HCT) must have no evidence of ongoing GVHD and be off GVHD treatment immunosuppression for at least 6 weeks at time of enrollment
Patients must have normal elastography
If ferritin is elevated, patient must have less than 7 mg/g liver iron concentration on liver T2\* MRI
Patients should have an official gastrointestinal (GI) consult prior to the transplant for full evaluation
Patients must have an HLA-matched related donor or an HLA-matched unrelated donor who meets standard Fred Hutch and/or National Marrow Donor Program (NMDP) or other donor center criteria for peripheral blood stem cell (PBSC) or bone marrow donation, as follows:
Related donor: related to the patient and genotypically or phenotypically identical for HLA-A, B, C, DRB1 and DQB1; phenotypic identity must be confirmed by high-resolution typing
Unrelated donor:
Matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing; OR
Mismatched for a single allele without antigen mismatching at HLA-A, B, or C as defined by high resolution typing but otherwise matched for HLA-A, B, C, DRB1 and DQB1 by high resolution typing
Donors are excluded when preexisting immunoreactivity is identified that would jeopardize donor hematopoietic cell engraftment; the recommended procedure for patients with 10 of 10 HLA allele level (phenotypic) match is to obtain panel reactive antibody (PRA) screens to class I and class II antigens for all patients before HCT; if the PRA shows \> 10% activity, then flow cytometric or B and T cell cytotoxic cross matches should be obtained; the donor should be excluded if any of the cytotoxic cross match assays are positive; for those patients with an HLA Class I allele mismatch, flow cytometric or B and T cell cytotoxic cross matches should be obtained regardless of the PRA results; a positive anti-donor cytotoxic crossmatch is an absolute donor exclusion
Patient and donor pairs homozygous at a mismatched allele in the graft rejection vector are considered a two-allele mismatch, i.e., the patient is A\*0101 and the donor is A\*0102, and this type of mismatch is not allowed
Exclusion
Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
Left ventricular ejection fraction \< 35%
Corrected diffusing capacity of the lungs for carbon monoxide (DLCO) \< 35% or receiving supplemental continuous oxygen; when pulmonary function test (PFT)s cannot be obtained, the 6-minute walk test (6MWT, also known as exercise oximetry) will be used: Any patient with oxygen saturation on room air of \< 89% during a 6MWT will be excluded
Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease
Patients who are known to be seropositive for human immunodeficiency virus (HIV)
Perceived inability to tolerate diagnostic or therapeutic procedures
Active central nervous system (CNS) leukemia at time of treatment
Patients with prior myeloablative allogeneic-HCT
Women of childbearing potential who are pregnant (beta-human chorionic gonadotropin positive \[beta-HCG+\] or breast feeding
Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant
Inability to understand or give an informed consent
Allergy to murine-based monoclonal antibodies
Known contraindications to radiotherapy
What this trial measures
- Incidence of dose limiting toxicity (DLT)Up to 30 days post-transplant, with a review period for occurrence of veno-occlusive disease (VOD)/sinusoidal obstruction syndrome (SOS) extended to 60 days post-transplant
DLT is defined as a grade III/IV regimen-related toxicity (Bearman scale). The maximum tolerated dose will be defined as the dose of 211\^At-BC8-B10 used in combination with the reduced-intensity hematopoietic cell transplantation conditioning regimen that is associated with a grade III/IV regimen-related toxicity or true DLT rate of 25%. The data, thereby generating a dose-response curve based on the observed toxicity rate at the various dose levels visited. Based on this fitted model, the maximum tolerated dose is estimated to be the dose that is associated with a toxicity rate of 25%.