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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|
Research Study Description
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 donors 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)
- 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)
- 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.
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)
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