Study on Chemotherapy and Radiation Therapy Followed by Donor Cell Transplant for Treating Older Adults with High-Risk Acute Myeloid Leukemia or Other Severe Blood Cancers
Sponsor: Fred Hutchinson Cancer Center
ClinicalTrials ID:NCT07046078
This clinical trial is exploring a new treatment approach for adults aged 60 and older with newly diagnosed high-risk acute myeloid leukemia (AML) or other severe blood cancers. The study combines chemotherapy, reduced-intensity radiation therapy, and a donor cell transplant to improve treatment outcomes and reduce side effects.
Patient Parameters
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Program Overview
The purpose of this study is to test a new treatment method for older adults with high-risk acute myeloid leukemia (AML) or other severe blood cancers. The treatment involves a combination of chemotherapy drugs, followed by lower-dose radiation therapy and a transplant of healthy blood-forming cells from a donor. This approach aims to effectively treat cancer cells while reducing the period of low blood cell counts, which can lead to infections and other complications. The study hopes to improve the chances of successful treatment and reduce the risks associated with low blood counts in older adults undergoing a donor cell transplant.
Description
In this study, participants will receive a combination of chemotherapy drugs, including fludarabine, cytarabine, and idarubicin, along with a medication called G-CSF to help boost white blood cell production. This is followed by reduced-intensity total body radiation therapy (TBI) and a transplant of healthy blood-forming cells from a donor. The treatment aims to kill cancer cells and prepare the body for the donor cell transplant, which can help restore healthy blood cell production.
Participants will undergo various tests and procedures, including heart and bone marrow evaluations, to monitor their health and the treatment's effectiveness. After completing the treatment, participants will have follow-up visits at specified intervals to assess their recovery and any side effects.
The study is designed to be safe and tolerable for older adults, with the goal of improving treatment outcomes and reducing the risks associated with low blood cell counts. By using a combination of chemotherapy, radiation, and donor cell transplant, the study aims to offer a more effective treatment option for older adults with high-risk AML or other severe blood cancers.
Eligibility Criteria
Inclusion Criteria
- Adults aged 60 and older, or younger adults unsuitable for more intense treatments.
- Ability to understand and sign a consent form, or have a representative do so.
- Newly diagnosed with high-risk acute myeloid leukemia (AML) or other severe blood cancers.
- Interested in undergoing a donor cell transplant.
- Have a caregiver available to assist during treatment.
- Good overall health, with a performance status score of 70 or higher.
- Adequate liver and kidney function based on specific blood tests.
- Women of childbearing potential must use effective contraception and have a negative pregnancy test.
- HIV-positive patients must have an undetectable viral load on treatment.
- Patients with hepatitis B or C must have controlled or treated infections.
- Must have a suitable donor for the cell transplant, meeting specific criteria for compatibility.
Exclusion Criteria
- Active disease affecting the central nervous system.
- Severe heart or lung conditions that prevent undergoing a donor cell transplant.
- Current treatment with other anti-leukemia medications.
- Other serious illnesses with a life expectancy of less than one year.
- Active infections not controlled by treatment.
- Allergies or contraindications to any study medications.
- Pregnant or breastfeeding women.
- Mental health or social issues that would prevent following study requirements.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | 98109 | Seattle | Washington |
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