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Leukemia, Myeloid, AcutePhase 1NCT01468467

A Study of AC220 Given After Transplant in Subjects With Acute Myeloid Leukemia (AML)

A Phase 1 study testing AC220 in people with Leukemia, Myeloid, Acute, run by Daiichi Sankyo at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
AC220
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
5 sitesUnited States
Study dates
Apr 2012to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • City of Hope

    Duarte, California, 91010

  • M.D. Anderson Cancer Center

    Houston, Texas, 77030

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

This is a two-part, sequential group dose escalation study.

In Part 1, subjects will be enrolled into successive cohorts to determine the maximum tolerated dose (MTD). Dose escalation decision will be made based on dose limiting toxicities (DLTs) that occur in subjects treated to date at a given dose level. In Part 2, a confirmation cohort will be opened to confirm the safety at the MTD.

Subjects who have had an allogeneic Hematopoietic Stem Cell Transplant (HSCT) will enter treatment with AC220 between 30 to 60 days after receiving allogeneic HSCT. AC220 will be administered every day, with 28 consecutive days defined as a treatment cycle. Subjects may receive up to 24 continuous treatment cycles. Subjects will have study visits each week for the first 2 cycles, and then on Day 1 of each cycle after that.

Being tested
AC220
Keywords
AC220, Acute Myeloid Leukemia (AML), Transplantation, Stem Cell Transplantation, Allogeneic Transplantation, FMS-like tyrosine kinase (FLT3), FMS-like tyrosine kinase (FLT3) Inhibitor, Kinase, Kinase Inhibitor, Pharmacokinetics, ASP2689, quizartinib
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AC220Drug

    Also called quizartinib, ASP2689

    Oral Liquid

Study groups in NCT01468467
Study groupRoleWhat they receive
AC220ExperimentalNot described
Receives: Drug: AC220

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose limiting toxicity (DLT)

    From first dose through last dose of Cycle 2

    Measured: up to Day 56

  2. Safety assessed by recording adverse events, physical examinations, vital signs, electrocardiograms (ECGs) and laboratory assessments

    Measured: 30 days after last subject discontinues treatment (maximum of 24 months)

Secondary outcomes (9)

  1. Duration of confirmed complete remission (CR)

    Time from first dose until date of relapse

    Measured: 24 months

  2. Duration of overall complete remission

    Complete remission (CR) + CR with incomplete platelet recovery (CRp) + CR with incomplete hematologic recovery (CRi) + complete molecular remission (CRm)

    Measured: 24 months

  3. Disease-free survival

    Time from first dose until date of relapse or death

    Measured: 30 days after last subject discontinues treatment (maximum of 24 months)

  4. Overall survival

    Time from first dose until date of death from any cause

    Measured: 30 days after last subject discontinues treatment (maximum of 24 months)

  5. Percentage of transplant rejections

    Through End of Treatment

    Measured: 30 days after last subject discontinues treatment (maximum of 24 months)

  6. Percentage of Subjects with Graft-versus-Host Disease (GVHD)

    Measured: Up through 24 months of treatment

  7. Percentage of Donor Chimerism

    Measured: Up through 24 months of treatment

  8. Treatment-related mortality (TRM)

    Death in CR (CR, CRm, CRp and CRi)

    Measured: Up through 24 months of treatment

  9. Composite of pharmacokinetics: AUC24 , Cmax, Ctrough and Tmax

    Measured: Up through 24 months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Nov 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionMar 2015
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01468467
Sponsor's protocol ID
2689-CL-0011
Status last verified
Nov 2016
First submitted
7 Nov 2011
Last updated
12 Feb 2019
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: 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/

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AC220 in people with Leukemia, Myeloid, Acute, run by Daiichi Sankyo at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (DLT) (time frame: up to Day 56). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01468467.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2019.

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