Radioimmunotherapy + Stem Cell Transplant for Leukemia and Myelodysplastic Syndrome

Palo Alto (17 mi)

Overseen byPhuong Vo

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Fred Hutchinson Cancer Research Center

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial studies a new treatment for patients with certain types of blood cancer that have returned or are not responding to treatment. The process includes treatments to clear out unhealthy cells, followed by a transplant of healthy cells from a donor to help rebuild the patient's blood cells.

Eligibility Criteria

This trial is for adults aged 18-75 with high-risk acute leukemia or myelodysplastic syndrome that's recurrent or refractory. Eligible patients must have certain types of leukemia, adequate organ function, and no uncontrolled infections. They can't have an HLA-matched donor available, severe heart/liver conditions, active HIV/CNS leukemia, be pregnant/breastfeeding, or unable to consent.

Inclusion Criteria

I can take care of myself and perform daily activities without help.

My tissue type matches the recipient's requirements.

I do not have any infections that aren't responding to treatment.

I have been diagnosed with AML, ALL, high-risk MDS, or MPAL.

I am between 18 and 75 years old.

I do not have a specific type of compatible donor for a transplant.

Exclusion Criteria

My lung function is severely reduced or I need extra oxygen.

I am currently pregnant or breastfeeding.

I have had a bone marrow transplant from a donor.

I am allergic to certain mouse-derived cancer drugs.

I cannot undergo radiotherapy due to health reasons.

I have liver issues such as cirrhosis or alcoholic hepatitis.

My leukemia has spread to my brain or spinal cord.

I am able to understand and give informed consent.

I am fertile and not willing to use birth control.

Treatment Details

The trial tests a radioactive antibody (211At-BC8-B10) followed by a stem cell transplant from a donor to treat high-risk blood cancers. It includes chemotherapy and total body irradiation to prepare the bone marrow for new cells and medications post-transplant to prevent graft versus host disease.

1Treatment groups

Experimental Treatment

Group I: Treatment (211At-BC8-B10, chemotherapy, TBI, MMF, G-CSF)Experimental Treatment11 Interventions

PREPARATIVE REGIMEN: Patients receive astatine At 211 anti-CD45 monoclonal antibody BC8-B10 infusion over 6-8 hours on day -8, fludarabine IV over 30 minutes on days -6 to -2, and cyclophosphamide IV over 1 hour on days -6 and -5. Patients also undergo TBI on day -1. TRANSPLANT: Patients undergo PBSC or bone marrow transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4, mycophenolate mofetil IV or PO TID on days 5-35, and tacrolimus IV over 1-2 hours (changed to PO once tolerated) on days 5-180 with taper beginning on day 84 per physician discretion. Patients also begin G-CSF IV or SC on day 5 to continue until ANC \> 1000/mm\^3 x 3 days. Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study.