Health Trials

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

ConditionsAcute Lymphoblastic LeukemiaAcute Myeloid Leukemia Arising From Previous Myelodysplastic SyndromeAcute Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic Syndrome With Excess BlastsRecurrent Acute Myeloid LeukemiaRefractory Acute Lymphoblastic LeukemiaRecurrent Acute Lymphoblastic LeukemiaRecurrent Mixed Phenotype Acute LeukemiaRefractory Acute Myeloid LeukemiaRefractory Mixed Phenotype Acute LeukemiaMixed Phenotype Acute Leukemia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFred Hutchinson Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Cyclosporine
  • Fludarabine Phosphate
  • Mycophenolate Mofetil
  • Peripheral Blood Stem Cell Transplantation
  • Pretargeted Radioimmunotherapy
  • Total-Body Irradiation
  • Pretargeted Radioimmunotherapy
  • Biospecimen Collection
  • Single Photon Emission Computed Tomography

Treatment groups

75 Participants
are divided into 1 treatment group

Sponsors and collaborators

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov