Clinical Trial Detail

The purpose of this study is to learn more about an experimental, two-part treatment for patients with advanced acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), or high-risk myelodysplastic syndrome (MDS). This study will look at the effects, good or bad, that this combined treatment has on the body and leukemia or MDS. The study will also help us determine the highest dose of radiation we can give safely. The two parts of the treatment are:

• targeted radiolabeled antibody therapy, followed by

• bone marrow transplant from a related, mismatched donor

The type of bone marrow transplant in this study has been used before to treat leukemia, MDS and other similar diseases. It has been effective in getting the donor’s stem cells to “take hold” in the recipient, but many patients relapse (the disease returns) after transplant. We want to find out if using the radiolabeled antibody before the transplant will reduce the number of patients who relapse after transplant.

Participants will receive treatment as outpatients at the Seattle Cancer Care Alliance (SCCA) and as inpatients at the University of Washington Medical Center (UWMC). The radiation used in the study requires participants to stay in a “radiation isolation” room at UWMC for about 5 to 10 days.

Participants in this study will need to be in Seattle for about 4 months. This includes about 3 weeks from the start of study participation until the bone marrow transplant, and then about 3 months of follow-up after the transplant.

- 1) Males or females with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS)

- AML or ALL patients must have disease that has either:

- a) come back after first remissi

- b) did not respond to initial treatmtent

OR

- c) evolved from myelodysplastic or myeloproliferative syndrome

- MDS patients must have one of the following:

- a) refractory anemia with excess blasts (RAEB),

- b) RAEB in transformation (RAEBT),

- c) refractory cytopenia with multilineage dysplasia (RCMD),

- d) RCMD with ringed sideroblasts (RCMD-RS

OR

- e) chronic myelomonocytic leukemia (CMML)

- 2) . Must be 18 years of age or older

- 3) Must have normal liver and kidney function

- 4) Must be physically able to meet study requirements

- 5) Must not have active infection

- 6) Must have a related donor who meets study guidelines

Other eligibility criteria may apply.

- 1) Already received maximum radiation to any organ

- 2) Severe heart problems requiring medication, or symptoms of coronary artery disease

- 3) Severe lung or liver problems

- 4) HIV positive

- 5) Medical or other condition that may prevent the patient from finishing the study

- 6) Pregnant or breast feeding

Other exclusion criteria may apply.