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 States333 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 range18 Years – 85 Years
SexALL
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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
✕. 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
✕
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
. 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.