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Protocol No. UW18086

Principal Investigator Hall, Aric

Phase II

Age Group Adult

Scope National

Sponsor Type Institutional

Title A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion Cell Vaccine versus Observation in Patients who Achieve a Chemotherapy-induced Remission

Objective
We want to find out if a cancer vaccine called Dendritic Cell/Acute Myelogenous Leukemia Fusion vaccine can stop or slow AML that is newly diagnosed or has returned for the first time. We also want to find out if the DC/AML vaccine is safe to use to treat AML

Treatment
Randomized to Arm A or Arm C:
  • Arm A: DC/AML vaccine: Leukapheresis will be performed followed by standard of care consolidation(1-4 cycles), followed by 3 vaccines(the first one will be given approximately 4-8 weeks after the completion of chemotherapy, then given every 4 weeks
  • Arm C: Observation: Standard of care consolidation(1-4 cycles)

  • Description A Randomized Phase II Clinical Trial of Dendritic Cell/AML Fusion cell vaccine versus observation in patients who achieve a chemotherapy-induced remission

    Key Eligibility
  • Patients must have AML at initial diagnosis or at first relapse
  • Patients must be less than or equal to 55 years old
  • ECOG performance status 0- 2
  • Must have normal organ and marrow function as defined by the protocol
  • Women of child-bearing potential and men must agree to use adequate contraception as defined by the protocol
  • Must have obtained a complete remission with chemotherapy defined by the absence of circulating blasts, and less than 5% blasts on bone marrow examination following hematopoietic recovery
  • Required no more than 2 cycles of chemotherapy or 4 cycles of a hypomethylating agent to achieve remission
    EXCLUSION
  • Active or prior documented autoimmune or inflammatory disorders as defined by the protocol
  • Have received a prior allogeneic transplant
  • Patients who have a known human immunodeficiency virus (HIV), untreated hepatitis C virus (HCV) or evidence of active hepatitis B virus (HBV)
  • Must not have active significant cardiac disease characterized by symptomatic congestive heart failure, unstable angina pectoris, clinically significant cardiac arrhythmia
  • No active infection
  • Current or prior use of immunosuppressive medication within 14 days prior to first vaccine
  • Can not be pregnant or breastfeeding

  • Applicable Disease Sites Leukemia

    Status Open

    Participating Institutions UW Hospital and Clinics