Study on Chemotherapy and Total-Body Radiation Followed by Donor Stem Cell Transplant for Treating High-Risk Myeloid Cancers
Sponsor: Fred Hutchinson Cancer Center
ClinicalTrials ID:NCT06928662
This clinical trial is testing a combination of chemotherapy, total-body radiation, and donor stem cell transplant to treat adults with certain blood cancers that are likely to return after treatment. The study aims to find the safest and most effective dose of the chemotherapy drug decitabine when used with other treatments.
Patient Parameters
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Program Overview
This study is exploring a treatment for adults with high-risk blood cancers, such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and chronic myelomonocytic leukemia (CMML). The treatment involves a combination of chemotherapy drugs, total-body radiation, and a stem cell transplant from a donor. The goal is to see if this approach can better prevent the cancer from coming back compared to standard treatments. Chemotherapy drugs work by killing cancer cells or stopping them from growing, while radiation therapy targets cancer cells throughout the body. The donor stem cell transplant helps replace the patient's bone marrow with healthy cells, potentially improving blood cell production and reducing cancer risk.
Description
In this study, patients will receive a combination of chemotherapy drugs, including decitabine, fludarabine, cytarabine, filgrastim, and idarubicin, along with total-body irradiation (TBI) before undergoing a stem cell transplant from a donor. The chemotherapy drugs work in different ways to stop cancer cells from growing and spreading. Filgrastim helps the body produce more white blood cells, which are important for fighting infections. Total-body irradiation uses high-energy rays to kill cancer cells throughout the body.
Patients will receive decitabine through an IV for several days, followed by other chemotherapy drugs and TBI. After this, they will receive healthy stem cells from a donor to help their bone marrow produce normal blood cells. The study will monitor the safety and effectiveness of this treatment combination.
Participants will undergo various tests, including heart and lung function tests, chest X-rays, and bone marrow biopsies, to ensure they are eligible and to monitor their health during the study. After completing the treatment, patients will have follow-up visits at 6 months, 1 year, and 2 years to check their progress.
Eligibility Criteria
Inclusion Criteria
- Adults aged 18 or older with a specific type of blood cancer that is at high risk of returning.
- Must have a good overall health status and heart function.
- Must have adequate liver and kidney function.
- Must have a suitable donor for the stem cell transplant.
- Must be able to understand and sign a consent form.
- Must not have any active infections or other serious health conditions.
- Women must not be pregnant or breastfeeding and must agree to use contraception during the study.
Exclusion Criteria
- Active disease in the central nervous system.
- Serious health conditions that limit life expectancy to less than one year.
- Active infections that are not controlled or stable.
- Allergies to any of the study drugs.
- Pregnancy or breastfeeding.
- Receiving other treatments for leukemia.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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