Astatine-211 for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen byBrenda M. Sandmaier

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Fred Hutchinson Cancer Research Center

Must not be taking: Cardiac medications

Disqualifiers: Coronary artery disease, HIV, others

No Placebo Group

Trial Summary

What is the purpose of 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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Eligibility Criteria

This trial is for patients with high-risk leukemias or myelodysplastic syndromes who have relapsed after remission, are not responding to treatments, or have disease evolved from other blood disorders. They must have low levels of leukemia cells in the blood and normal kidney and liver function. It's not suitable for those in first remission without measurable residual disease.

Inclusion Criteria

I am mostly active and can care for myself.

Patients should have a circulating blast count of less than 10,000/mm^3

Patients must have normal elastography

+9 more

Exclusion Criteria

Patients who are known to be seropositive for human immunodeficiency virus (HIV)

I have had a bone marrow transplant from a donor.

Perceived inability to tolerate diagnostic or therapeutic procedures

+10 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 211^At-BC8-B10 IV, potentially 131^I-BC8-B10 IV, fludarabine phosphate IV, undergo TBI and PBSC transplant, and receive cyclosporine and mycophenolate mofetil

Approximately 8 weeks

Multiple visits for IV administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including SPECT, bone marrow aspirate, and blood sample collection

Up to 24 months

Follow-up visits at 100 days, 6, 9, 12, 18, and 24 months

Participant Groups

The trial tests a radioactive drug (211^At-BC8-B10) given before a stem cell transplant from a donor. The goal is to see how well it works at killing cancer cells while sparing healthy ones, determining the best dose and assessing side effects.

1Treatment groups

Experimental Treatment

Group I: Treatment (211^At-BC8-B10, PBSC)Experimental Treatment8 Interventions

Patients receive 211\^At-BC8-B10 IV over 6-8 hours on day -7 and may receive 131\^I-BC8-B10 IV on day -7 and fludarabine phosphate IV over 30 minutes on days -4, -3 and -2. Patients undergo TBI and PBSC transplant on day 0. Patients also receive cyclosporine PO or IV every 12 hours on days -3 to 56 and then tapered to day 180, or continuing to day 96 and then tapered to day 150. Patients receive mycophenolate mofetil PO or IV (first dose to occur 4-6 hours after PBSC infusion) every 12 hours on days 0-27 (for patients with related donors) or every 8 hours on day 0 and then reduced to every 12 hours on days 30-150 then tapered to day 180 (for patients with unrelated donors). Patients may undergo SPECT, bone marrow aspirate sample and blood sample collection on study.