211At-BC8-B10 Followed by Donor Stem Cell Transplant in Treating Patients With Relapsed or Refractory High-Risk Acute Leukemia or Myelodysplastic Syndrome

Summary

This phase I/II trial studies the side effects and best dose of a radioactive agent linked to an antibody (211At-BC8-B10) followed by donor stem cell transplant in treating patients with high-risk acute leukemia or myelodysplastic syndrome that has come back (recurrent) or isn't responding to treatment (refractory). 211At-BC8-B10 is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Giving chemotherapy and total body irradiation before a stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. When the healthy stem cells from a donor are infused into the patient, they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can attack the body's normal cells, called graft versus host disease. Giving cyclophosphamide, mycophenolate mofetil, and tacrolimus after a transplant may stop this from happening.

Conditions

• Acute Lymphoblastic Leukemia in Remission
• Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
• Acute Myeloid Leukemia in Remission
• Chronic Myelomonocytic Leukemia
• Myelodysplastic Syndrome With Excess Blasts
• Recurrent Acute Lymphoblastic Leukemia
• Recurrent Acute Myeloid Leukemia
• Refractory Acute Lymphoblastic Leukemia
• Refractory Acute Myeloid Leukemia
• Recurrent Mixed Phenotype Acute Leukemia
• Refractory Mixed Phenotype Acute Leukemia
• Hematopoietic and Lymphoid Cell Neoplasm

Interventions

BIOLOGICAL

Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

Given via infusion

DRUG

Cyclophosphamide

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo PBSC transplantation

PROCEDURE

Bone Marrow Transplantation

Undergo bone marrow transplant

DRUG

Mycophenolate Mofetil

Given IV or PO

BIOLOGICAL

Recombinant Granulocyte Colony-Stimulating Factor

Given IV or SC

DRUG

Fludarabine Phosphate

Given IV

DRUG

Tacrolimus

Given IV or PO

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Fred Hutchinson Cancer Center

  lead OTHER

Principal Investigators

• Phuong Vo · Fred Hutchinson Cancer Center

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

2019-07-10

Primary Completion

2028-01-28

Completion

2029-10-20

FDA Drug

Yes

Countries

• United States

Study Locations