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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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Cyclosporine

    Drug

    Given PO or IV

  • Fludarabine Phosphate

    Drug

    Given IV

  • Mycophenolate Mofetil

    Drug

    Given PO or IV

  • Peripheral Blood Stem Cell Transplantation

    Procedure/Surgery

    Undergo allogeneic PBSC transplant

  • Pretargeted Radioimmunotherapy

    Radiation

    Given 211\^At-BC8-B10 IV

  • Total-Body Irradiation

    Radiation

    Undergo TBI

  • Pretargeted Radioimmunotherapy

    Radiation

    Given 131\^I-BC8-B10 IV

  • Biospecimen Collection

    Procedure/Surgery

    Undergo blood and bone marrow aspirate sample collection

  • Single Photon Emission Computed Tomography

    Procedure/Surgery

    Undergo SPECT

Treatment groups

75 Participants
are divided into 1 treatment group
Group A: Treatment (211^At-BC8-B10, PBSC)Experimental treatment 8 interventions

Trial outcomes

Primary outcomes

1

Incidence of dose limiting toxicity (DLT)

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%.

Time frame
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

Secondary outcomes

1

Engraftment

Sufficient evidence will be taken to be a lower limit of the appropriate 80% one-sided confidence interval associated with the estimated proportion of rejections in excess of 0.20.

Time frame
Up to day 100
2

Chimerism

Time frame
Up to day 84
3

Non-relapse mortality

Time frame
Up to 2 years
4

Acute graft versus host disease

Time frame
Up to day 180

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fred Hutchinson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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