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Complete title: A Phase II Trial Combining Radiolabeled BC8 (Anti-CD45) Antibody with Fludarabine and Low Dose TBI Followed by Related or Unrelated PBSC Infusion and Post-Transplant Immunosuppression for Patients with Advanced AML or High Risk Myelodysplastic Syndrome
|Research Study Number||1809.00|
|Principal Investigator||John Pagel, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- Patients with advanced AML defined as beyond first remission, primary refractory disease, or evolved from myelodysplastic or myeloproliferative syndromes; or patients with MDS expressed as refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEBT), refractory cytopenia with multilineage dysplasia (RCMD), RCMD with ringed sideroblasts (RCMD-RS), or chronic myelomonocytic leukemia (CMML)
- Patients not in remission must have cluster of differentiation (CD)45-expressing leukemic blasts or myelodysplastic cells; patients in remission do not require phenotyping and may have leukemia previously documented to be CD45 negative (because in remission patients, virtually all antibody binding is to non-malignant cells which make up > 95% of nucleated cells in the marrow)
- Patients should have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea or similar agent is allowed)
- Patients must have an estimated creatinine clearance greater than 50/ml per minute (serum creatinine value must be within 28 days prior to registration)
- Bilirubin < 2 times the upper limit of normal
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times the upper limit of normal
- Karnofsky score >= 70 or Eastern Cooperative Oncology Group (ECOG) =< 2
- Patients must have an expected survival of > 60 days and must be free of active infection
- Patients must have an HLA-identical sibling donor or an HLA-matched unrelated donor who meets standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC donation; related donors should be matched by molecular methods at the intermediate resolution level at HLA-A, B, C, and DRB1 according to Fred Hutchinson Cancer Research Center (FHCRC) Standard Practice Guidelines and to the allele level at DQB; unrelated donors should be identified using matching criteria that follows the FHCRC Standard Practice Guidelines limiting the study to eligible donors that are allele matched for HLA-A, B, C, DRB1, and DQB1 (Grade 1), and accepting up to one allele mismatch as per Standard Practice Grade 2.1 for HLA-A, B, or C
- DONOR: Donors must meet HLA matching criteria as well as standard Seattle Cancer Care Alliance (SCCA) and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC donation
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- Prior radiation to maximally tolerated levels to any normal organ
- Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
- Inability to understand or give an informed consent
- Patients who are seropositive for human immunodeficiency virus (HIV)
- Perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation
- Patients who have previously undergone autologous or allogeneic HSCT
Other exclusion criteria may apply.
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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