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Iodine I 131 Monoclonal Antibody BC8, Fludarabine Phosphate, Cyclophosphamide, Total-Body Irradiation and Donor Bone Marrow Transplant in Treating Patients With Advanced Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia or High-Risk Myelodysplastic Syndrome

Complete title: Hematopoietic Bone Marrow Transplantation for Patients with High-Risk Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS) using Related HLA-Mismatched Donors: A Trial Using Radiolabeled Anti-CD45 Antibody Combined with Immunosuppression Before and After Transplantation

Research Study Number       2186.00
Principal Investigator       John Pagel, MD, PhD
Phase       II

Look up trial at NIH

Research Study Description

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.

Eligibility Criteria (must meet the following to participate in this study)

- 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


- 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


- 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.

Exclusions (conditions that would prevent participation in this study)

- 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.

Research Study Number       2186.00
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Acute Lymphoid Leukemia (ALL); Acute Myeloid Leukemia (AML); Bone Marrow and Hematopoietic Stem Cell Transplant (BMT and HSCT); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)

Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:

  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.

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