Study on Radioactive Antibody and Donor Stem Cell Transplant for Treating Relapsed or Hard-to-Treat High-Risk Acute Leukemia or Myelodysplastic Syndrome
Sponsor: Fred Hutchinson Cancer Center
ClinicalTrials ID:NCT03670966
This clinical trial is testing a new treatment that combines a radioactive antibody with a donor stem cell transplant to help patients with high-risk acute leukemia or myelodysplastic syndrome that has returned or isn't responding to treatment. The study aims to find the best dose and understand the side effects of this approach.
Patient Parameters
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Program Overview
This study is exploring a new treatment for patients with high-risk acute leukemia or myelodysplastic syndrome that has come back or isn't responding to treatment. The treatment involves using a radioactive antibody called 211At-BC8-B10, which may help stop cancer cells from growing and spreading. Patients will also receive chemotherapy and total body irradiation to prepare for a stem cell transplant from a donor. This process helps replace the patient's bone marrow with healthy cells that can produce new blood cells. To prevent the donor cells from attacking the patient's body, medications like cyclophosphamide, mycophenolate mofetil, and tacrolimus are given after the transplant.
Description
In this study, patients will receive a radioactive antibody treatment called 211At-BC8-B10, which is designed to target and destroy cancer cells. This is followed by chemotherapy and total body irradiation to prepare the body for a stem cell transplant. The transplant involves infusing healthy stem cells from a donor into the patient to help restore normal blood cell production.
To prevent complications where the donor cells attack the patient's body, known as graft versus host disease, patients will receive medications such as cyclophosphamide, mycophenolate mofetil, and tacrolimus. These medications help protect the patient's body while the new stem cells begin to work.
Throughout the study, patients will have regular check-ups, including bone marrow biopsies and blood tests, to monitor their progress. After completing the treatment, patients will be followed up at specific intervals to ensure their health and recovery.
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS), or mixed phenotype acute leukemia (MPAL) that meets specific conditions, such as being in remission with residual disease or having relapsed.
- Must be 18 to 75 years old.
- Must have a low number of cancer cells in the blood, which can be controlled with medication if needed.
- Must have good kidney function and normal liver enzyme levels.
- Must be in good general health, with a performance status that allows for daily activities.
- Must not have any uncontrolled infections.
- Must have a suitable donor who matches certain genetic criteria for the stem cell transplant.
- Must have a gastrointestinal evaluation before the transplant.
- Must have normal liver function and iron levels if ferritin is elevated.
Exclusion Criteria
- Cannot have serious heart disease or be on certain heart medications.
- Cannot have poor lung function or need continuous oxygen.
- Cannot have severe liver problems or active liver disease.
- Cannot be HIV positive.
- Cannot have active leukemia in the central nervous system.
- Cannot have had a previous myeloablative stem cell transplant.
- Cannot be pregnant or breastfeeding, and must agree to use contraception if of childbearing potential.
- Cannot have allergies to the study medications or known issues with radiation therapy.
- Must be able to understand and agree to the study procedures.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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