Receive a new drug combination before stem cell transplant for aggressive blood cancer

Back to Acute Myeloid Leukemia (AML) trials

Recruiting

What is this trial?

This trial is testing whether a three-drug combination called thiotepa, busulfan, and fludarabine—given as preparation before a stem cell transplant—can help older adults with high-risk acute myeloid leukemia (AML) live longer without their cancer returning. The goal is to see if this new medication combination is safe and effective for preparing the body to accept stem cells from a partially matched family member. Researchers will track how well this treatment works and how patients tolerate it over the first year.

Acute myeloid leukemia is a serious blood cancer, especially when it returns after treatment or doesn't respond to standard chemotherapy. Stem cell transplants offer hope, but doctors need to find the safest and most effective ways to prepare older patients' bodies before the transplant—this medication combination may be a better option than current approaches.

Do you qualify?

You likely qualify if…

you are between 55 and 70 years old
you have been diagnosed with high-risk acute myeloid leukemia (including leukemia that has returned, didn't respond to treatment, or has specific genetic features)
you are scheduled to receive a stem cell transplant from a partially matched family member
your organs (heart, kidneys, liver, lungs) are working well enough for this treatment
you are well enough to undergo intensive treatment (Eastern Cooperative Oncology Group performance status of 2 or better)
you are willing to sign a consent form and follow the study plan

You likely don't qualify if…

you refuse or are unwilling to follow the treatment plan
you have antibodies that attack the donor's stem cells (donor-specific anti-HLA antibodies)
you have HIV infection
you have active hepatitis B or C, or ongoing liver inflammation from hepatitis
you have an uncontrolled active infection at the time you would enroll

What participation looks like

You would receive the study medication combination over about 10 days in the hospital to prepare your body for the transplant. The first chemotherapy drugs (thiotepa, busulfan, and fludarabine) are given on different days, along with other supportive medicines to help prevent rejection of the new stem cells. On day zero, you receive the stem cell infusion. After that, you will be monitored closely in the hospital and as an outpatient for at least one year, with regular blood tests and visits to track how well the treatment is working and manage any side effects.

New drug combination before stem cell transplant for high-risk blood cancer in older adults

What is this trial?

Do you qualify?

What participation looks like

Trial locations(1 site)