Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML) (NCT00989261) | Clinical Trial Compass
CompletedPhase 2
Efficacy Study for AC220 to Treat Acute Myeloid Leukemia (AML)
United States, Canada, France333 participantsStarted 2009-11
Plain-language summary
AC220 will be administered as a once daily oral solution given continuously as 28-day treatment cycles, without any rest periods, until disease progression, relapse, intolerance to the drug, or elective allogeneic hematopoietic stem cell transplantation (HSCT).
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Males and females age ≥18 years in second relapse or refractory.
. Males and females age ≥60 years in first relapse or refractory.
. Must have baseline bone marrow sample taken.
. Morphologically documented primary AML or AML secondary to myelodysplastic syndrome (MDS with ≥20% bone marrow or peripheral blasts), as defined by the World Health Organization (WHO) criteria, confirmed by pathology review at treating institution.
. Able to swallow the liquid study drug.
. Eastern Cooperative Oncology Group performance status of 0 to 2
. In the absence of rapidly progressing disease, the interval from prior treatment to time of AC220 administration will be at least 2 weeks for cytotoxic agents or at least 5 half-lives for noncytotoxic agents. The use of chemotherapeutic or antileukemic agents other than hydroxyurea is not permitted during the study with the possible exception of intrathecal (IT) therapy at the discretion of the Investigator and with the agreement of the Sponsor.
. Persistent chronic clinically significant non-hematological toxicities from prior treatment must be ≤Grade 1.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [+] Participants)
Timeframe: Within the first 3 cycles of treatment (84 days)
2
Derived Disease Assessment Based on Local Morphology Including All On-Treatment Data (Safety Population, FLT3-ITD [-] Participants)
Timeframe: Within the first 3 cycles of treatment (84 days)
3
Number of Participants With Composite Complete Remission (CRc), Categorised by FLT3-ITD Status
. Patients over the age of 85 years except at the discretion of the Investigator and with agreement of the Sponsor.
. Diagnosis of acute promyelocytic leukemia
. Diagnosis of chronic myelogenous leukemia (CML) in blast crisis
. AML in relapse or refractory after 3 or more previous lines of chemotherapy (and/or HSCT) treatment
. AML or antecedent MDS secondary to prior chemotherapy
. Persistent clinically significant non-hematological toxicity that is Grade \>1 by NCI CTCAE v4 from prior chemotherapy
. Patients who have had HSCT and are within 100 days of transplant and/or are still taking immunosuppressive drugs and/or have clinically significant graft-versus-host disease requiring treatment and/or have \>Grade 1 persistent non hematological toxicity related to the transplant
. Clinically active central nervous system (CNS) leukemia. Patients with CNS leukemia, which is controlled, but who are still receiving IT therapy at study entry may be considered eligible and continue receive IT therapy at the discretion of the Investigator and with agreement of the Sponsor.