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Acute Myeloid Leukemia (AML)

AC220 Post Transplant for Acute Myeloid Leukemia (2487)
A Phase 1 Study of AC220 (ASP2689) as Maintenance Therapy in Subjects With Acute Myeloid Leukemia Who Have Been Treated With an Allogeneic Hematopoietic Stem Cell Transplant
Status Conditions Phase Study ID
Closed Acute Myeloid Leukemia (AML) Phase I 2487.00
NCT01468467
Summary

The purpose of this study is to define a safe dose of AC220 when given as maintenance therapy after treatment with an allogeneic stem cell transplant.


Investigator
Brenda Sandmaier, MD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Subject has a diagnosis of acute myeloid leukemia (AML) according to WHO classification (2008) and has received a high dose or a reduced intensity conditioning allogeneic Hematopoietic Stem Cell Transplant (HSCT) during first or second remission and within 30 to 60 days prior to first dose of AC220. Donors may be human leukocyte antigen (HLA)-matched for HLA-A, B, C, DRB1, and DQB1 by high resolution typing, related or unrelated (only a single allele disparity will be allowed for HLA-A, B, or C as defined by high resolution typing)
  • Subject has documentation that is positive for FLT3-ITD activating mutation from initial diagnosis
  • Subject must be in morphologic remission (< 5% marrow blasts) and without active central nervous system (CNS) AML within 14 days prior to first dose of AC220
  • Subject must have CD3 donor chimerism > 50 % at Screening
  • Subject has a Karnofsky Performance Status (KPS) of ≥ 60
  • Subject must have absolute neutrophil count (ANC) > 1000/mm3 and platelet count > 50,000/mm3 without platelet transfusion support within 2 weeks prior to first dose
  • Subject must have adequate renal, hepatic, and coagulation parameters as indicated by the following laboratory values:

    • Alkaline phosphatase, aspartate aminotransferase (AST), alanine aminotransferase (ALT) ≤ 2.5 x institutional upper limit of normal (ULN)
    • Total bilirubin ≤ 1.5 x institutional ULN
    • Serum creatinine ≤ 1.5 x institutional ULN or an estimated glomerular filtration rate (eGFR) of > 50 ml/min as calculated by the Modification of Diet in Renal Disease (MDRD) equation
  • If subject is a woman of childbearing potential (WOCBP) or a male subject with female partner of childbearing potential, the subject agrees to use a medically-approved method of contraception to avoid pregnancy throughout the study and for at least 3 months after the last dose of study drug
  • If subject is a WOCBP, subject has a negative serum or urine pregnancy test (sensitivity ≤ 25 IU human chorionic gonadotropin [hCG]/L) within 72 hours prior to the start of study drug administration
  • Subject is able to comply with study procedures and follow-up examinations
Exclusions (conditions that would prevent participation in this study)
  • Subject received AC220 and relapsed during treatment with AC220
  • Subject has active ≥ Grade 2 graft versus host disease (GVHD)
  • Subject has received concurrent chemotherapy, immunotherapy, or radio-therapy within 21 days prior to the first dose of AC220, or any antineoplastic therapy that is considered to be investigational (i.e., used for non-approved indications(s) and in the context of a research investigation) within 30 days or 5 half-lives (whichever is longer) prior to the first dose of study drug
  • Subject requires treatment with concomitant drugs that prolong QT/QTc interval or strong cytochrome P-3A4 (CYP3A4) inhibitors or inducers with the exception of immunosuppressants, antibiotics, antifungals, and antivirals that are used as standard of care post-transplant or to prevent or treat infections and other such drugs that are considered absolutely essential for the care of the subject
  • Subject requires treatment with anticoagulant therapy
  • Subject has a known positive test for human immunodeficiency virus, hepatitis C, or hepatitis B surface antigen
  • Subject had major surgery within 4 weeks prior to first dose of AC220
  • Subject has uncontrolled or significant cardiovascular disease
  • Subject has an active acute fungal, bacterial, or other infection that is unresponsive to therapy
  • Subject is a female who is lactating
  • Subject has any medical, psychiatric, addictive or other kind of disorder which compromises the ability of the subject to give written informed consent and/or to comply with procedures
Last Updated
May 12, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.