Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome | Aplastic Anemia and MDS International Foundation

Clinical Trial: NCT01300572

Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Myelodysplastic Syndrome
For more details on this clinical trial, including contact information, please see this trial’s listing on clinicaltrials.gov:
Purpose: 

This phase I trial studies the side effects and maximum tolerated dose of yttrium Y 90 anti-cluster of differentiation 45 (CD45) monoclonal antibody BC8 (90Y-BC8) followed by donor stem cell transplant in treating patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), ormyelodysplastic syndrome (MDS) that is likely to come back or spread. Giving chemotherapy drugs, such as fludarabine phosphate (FLU), and total-body irradiation (TBI) before a donor peripheral blood stem cell (PBSC) or bone marrow 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.

Status: 
Recruiting
Study Date: 
Sun, 01/01/2012 to Thu, 12/01/2016
Bone Marrow Disease(s): 
myelodysplastic syndromes (MDS)
Intervention: 
Procedure: Allogeneic Bone Marrow Transplantation Undergo allogeneic bone marrow transplant Other Names: Allo BMT Allogeneic BMT Procedure: Allogeneic Hematopoietic Stem Cell Transplantation Undergo allogeneic PBSC or bone marrow transplant Other Names: allogeneic stem cell transplantation HSC HSCT Drug: Cyclosporine Given PO or IV Other Names: 27-400 Ciclosporin CsA Cyclosporin Cyclosporin A Neoral OL 27-400 Sandimmun Sandimmune SangCya Drug: Fludarabine Phosphate Given IV Other Names: 2-F-ara-AMP 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)- Beneflur Fludara Oforta SH T 586 Biological: Indium In 111 Anti-CD45 Monoclonal Antibody BC8 Given IV (dosimetric dose) Other Names: In 111 MOAB BC8 In 111 Monoclonal Antibody BC8 Indium In 111 Monoclonal Antibody BC8 monoclonal antibody BC8, indium In 111 Other: Laboratory Biomarker Analysis Correlative studies Drug: Mycophenolate Mofetil Given PO or IV Other Names: Cellcept MMF Procedure: Peripheral Blood Stem Cell Transplantation Undergo allogeneic PBSC transplant Other Names: PBPC transplantation Peripheral Blood Progenitor Cell Transplantation Peripheral Stem Cell Support Peripheral Stem Cell Transplantation Other: Pharmacological Study Correlative studies Radiation: Total-Body Irradiation Undergo TBI Other Names: TOTAL BODY IRRADIATION Whole-Body Irradiation Radiation: Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8 Given via central line (therapeutic dose) Other Name: 90Y Anti-CD45 MoAb BC8