XCancer

Yttrium-90 Anti-CD45 Monoclonal Antibody BC8 Followed by Donor Stem Cell Transplant in Treating Patients With High-Risk AML, ALL, or MDS

Description:

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), or myelodysplastic 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.

Sponsor:

Fred Hutchinson Cancer Center

Phase:

Phase 1

Contacts:

Brenda Sandmaier (PRINCIPAL_INVESTIGATOR)

Government Study Link:

NCT01300572 - Click here to see study on

ClinicalTrials.gov

BC8

Isotope(s):
Target(s):
  • CD45
Ligand Class: Antibodies
Chelator: DOTA
Inclusion
  • AML or ALL representing primary refractory disease (i.e., having failed to achieve remission at any time following one or more prior treatment regimens)
  • MDS expressed as refractory anemia with excess blasts (RAEB) or chronic myelomonocytic leukemia (CMML) by French-American-British (FAB) criteria
  • AML or ALL beyond first remission (i.e., having relapsed at least one time after achieving remission in response to a treatment regimen)
  • AML evolved from myelodysplastic or myeloproliferative syndromes; or
  • * Patients must have advanced AML, ALL or high-risk MDS meeting one of the following descriptions:
Exclusion
  • Patients may not have symptomatic coronary artery disease and may not be on cardiac medications for anti-arrhythmic or inotropic effects
  • 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)
  • * Circulating human anti-mouse antibody (HAMA)
  • Left ventricular ejection fraction \< 35%
  • Corrected diffusion lung capacity of carbon monoxide (DLCO) \< 35% or receiving supplemental continuous oxygen