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Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Peripheral Blood Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia or Myelodysplastic Syndrome

Complete title: A Study Evaluating Escalating Doses of 90Y-DOTA-BC8 (anti-CD45) Antibody followed by Allogeneic Stem Cell Transplantation for High-Risk Acute Myeloid Leukemia (AML) Acute Lymphoblastic Leukemia (ALL), or Myelodysplastic Syndrome (MDS).

Research Study Number       2468.00
    
Principal Investigator       Brenda Sandmaier, MD
    
Phase       I

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Research Study Description

This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-CD45 monoclonal antibody BC8 (90Y-BC8) followed by donor peripheral blood stem cell transplant (PBSC) in treating patients with high-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor PBSC transplant helps stop the growth of cancer or abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. Radiolabeled monoclonal antibodies, such as 90Y-BC8, can find cancer cells and carry cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving FLU, 90Y-BC8, and TBI before the transplant together with cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.

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

Ages Eligible for Study: 50 Years and older

Genders Eligible for Study: Both

- Patients must have advanced AML or high-risk MDS meeting one of the following descriptions:

- ** AML beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)

- ** AML representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)

- ** AML evolved from MDS or myeloproliferative syndromes; or

- ** MDS expressed as refractory anemia with excess blasts (RAEB)

- Patients not in remission must have cluster of differentiation (CD)45-expressing leukemic blasts; 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 must be >= 50 years of age

- 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

- Bilirubin < 2 times the upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 2 times the upper limit of normal

- 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 human leukocyte antigen (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 or bone marrow donation, as follows:

- ** Sibling donor; a patient and sibling donor should be matched for HLA-A, B, C, DRB1 and DQB1 by an intermediate resolution deoxyribonucleic acid (DNA)-based method

- ** Unrelated donor; an unrelated donor and recipient should be typed by a high resolution DNA-based method, and ideally matched for HLA-A, B, C, DRB1 and DQB1 alleles, or if there is only a single locus disparity mismatched for an HLA-DQB1 antigen or allele; an unrelated donor may also be mismatched for any single 1) one HLA-A, B or C antigen or allele, or 2) a single DR antigen or 3) a single DQ antigen or allele or 4) HLA-DRB1 allele (with or without matching for HLA-DQB1)

- DONOR: Donors must meet HLA matching criteria and standard SCCA and/or National Marrow Donor Program (NMDP) or other donor center criteria for PBSC or bone marrow donation

Other eligibility criteria may apply.

Exclusions (conditions that would prevent participation in this study)

- Circulating human anti-mouse antibody (HAMA)

- Prior radiation to maximally tolerated levels to any critical normal organ, or > 20 Gy prior radiation to large areas of the bone marrow (e.g., external radiation therapy to whole pelvis)

- Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects

- Left ventricular ejection fraction < 35%

- Corrected diffusion lung capacity of carbon monoxide (DLCO) < 35% or receiving supplemental continuous oxygen

- Liver abnormalities: fulminant liver failure, cirrhosis of the liver with evidence of portal hypertension, alcoholic hepatitis, esophageal varices, hepatic encephalopathy, uncorrectable hepatic synthetic dysfunction as evidenced by prolongation of the prothrombin time, ascites related to portal hypertension, bacterial or fungal liver abscess, biliary obstruction, chronic viral hepatitis, or symptomatic biliary disease

- Patients who are known to be seropositive for human immunodeficiency virus (HIV)

- Perceived inability to tolerate diagnostic or therapeutic procedures

- Active central nervous system (CNS) leukemia at time of treatment

- Women of childbearing potential who are pregnant (beta-human chorionic gonadotrophin [HCG+]) or breast feeding

- Fertile men and women unwilling to use contraceptives during and for 12 months post-transplant

- Inability to understand or give an informed consent

Other exclusion criteria may apply.



Research Study Number       2468.00
    
Contact       Seattle Cancer Care Alliance Intake Office
    
Telephone       800-804-8824 / 206-288-1024
    
   

Keywords
Acute Myeloid Leukemia (AML); Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)

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