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

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.

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

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

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Brenda M. Sandmaier · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-24

Primary Completion

2027-06-30

Completion

2029-03-31

FDA Drug

Yes

Countries

• United States

Study Locations