RecruitingPhase 1Phase 2NCT03670966

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

A Phase I/II Study Evaluating Escalating Doses of 211At-Labeled Anti-CD45 MAb BC8-B10 (211At-BC8-B10) Followed by Related Haplo-Identical Allogeneic Hematopoietic Cell Transplantation for High-Risk Acute Leukemia or Myelodysplastic Syndrome (MDS)


Sponsor

Fred Hutchinson Cancer Center

Enrollment

30 participants

Start Date

Jul 10, 2019

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing a specialized radioactive treatment (211At-BC8-B10) that targets cancer cells, followed by a donor stem cell transplant, for patients with leukemia or a high-risk bone marrow disorder (MDS) that is hard to treat with standard approaches. **You may be eligible if...** - You have been diagnosed with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk MDS, or a mixed type of leukemia (MPAL) - You are in first remission but still have traces of cancer detectable by testing, OR - Your cancer has relapsed (come back) or is hard to treat, OR - You have relapsed after a previous stem cell transplant - You have a matched donor (related or unrelated) available for stem cell transplant - You are in adequate health to undergo transplant **You may NOT be eligible if...** - You have cancer involving the brain or spinal fluid (central nervous system disease) - You have serious organ problems (heart, liver, kidney, or lungs) - You are pregnant or breastfeeding - You have active, uncontrolled infection - You have had prior radiation to levels that make further treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALAstatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10

Given via infusion

DRUGCyclophosphamide

Given IV

RADIATIONTotal-Body Irradiation

Undergo TBI

PROCEDUREPeripheral Blood Stem Cell Transplantation

Undergo PBSC transplantation

PROCEDUREBone Marrow Transplantation

Undergo bone marrow transplant

DRUGMycophenolate Mofetil

Given IV or PO

BIOLOGICALRecombinant Granulocyte Colony-Stimulating Factor

Given IV or SC

DRUGFludarabine Phosphate

Given IV

DRUGTacrolimus

Given IV or PO

PROCEDUREBone Marrow Aspiration and Biopsy

Undergo bone marrow biopsy and aspiration

PROCEDUREBiospecimen Collection

Undergo blood sample collection


Locations(1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

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NCT03670966


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