A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)
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
1 other identifier
interventional
13
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2012
Typical duration for phase_1
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2011
CompletedFirst Posted
Study publicly available on registry
November 9, 2011
CompletedStudy Start
First participant enrolled
April 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedFebruary 12, 2019
November 1, 2016
2.9 years
November 7, 2011
February 8, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of dose limiting toxicity (DLT)
From first dose through last dose of Cycle 2
up to Day 56
Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs) and laboratory assessments
30 days after last subject discontinues treatment (maximum of 24 months)
Secondary Outcomes (9)
Duration of confirmed complete remission (CR)
24 months
Duration of overall complete remission
24 months
Disease-free survival
30 days after last subject discontinues treatment (maximum of 24 months)
Overall survival
30 days after last subject discontinues treatment (maximum of 24 months)
Percentage of transplant rejections
30 days after last subject discontinues treatment (maximum of 24 months)
- +4 more secondary outcomes
Study Arms (1)
AC220
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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) Note: more than one HSCT is allowed
- 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
- Female subjects must not be lactating and must not be breastfeeding at Screening or during the study period and for 28 days \[or five half lives of the study drug whichever is longer\] after final study drug administration.
- Subject is able to comply with study procedures and follow-up examinations
You may not qualify if:
- 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 has participated in any interventional clinical study or has been treated with any investigational drugs within 30 days or 5 half lives whichever is longer, prior to the initiation of Screening.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Daiichi Sankyolead
- Ambit Biosciences Corporationcollaborator
Study Sites (5)
City of Hope
Duarte, California, 91010, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
M.D. Anderson Cancer Center
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle, Washington, 98109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Guy Gammon, MB, BS, MRCP
Medical Monitor, Ambit Biosciences Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2011
First Posted
November 9, 2011
Study Start
April 1, 2012
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
February 12, 2019
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication.
- Access Criteria
- Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/