An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subj… (NCT02577406) | Clinical Trial Compass
CompletedPhase 3
An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation
United States319 participantsStarted 2015-12-30
Plain-language summary
This is an international, multicenter, open-label, randomized, Phase 3 study comparing the efficacy and safety of AG-221 versus conventional care regimens (CCRs) in subjects 60 years or older with acute myeloid leukemia (AML) refractory to or relapsed after second- or third-line AML therapy and positive for an isocitrate dehydrogenase (IDH2) mutation.
Who can participate
Age range60 Years
SexALL
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Inclusion criteria
✓. Subject is ≥ 60 years of age at the time of signing the ICF
✓. Subject has primary (ie, de novo) or secondary (progression of MDS or myeloproliferative neoplasms (\[MPN\], or therapy-related) AML according to WHO classification (Appendix B)
✓. Subject has received second- or third-line of AML therapy (see Appendix G for the definition of prior AML line; note that, for subjects having AML secondary to prior higher risk \[Intermediate-2 or High risk according to the International Prognostic Scoring System\] MDS treated with a hypomethylating agent \[eg, azacitidine or decitabine\], the hypomethylating therapy can be counted as a line if there is disease progression to AML during or shortly \[eg, within 60 days\] after the hypomethylating therapy.)
✓. Subject has the following disease status:
✓. Refractory to or relapsed after second- or third-line of intensive therapy for AML (eg, the "7 + 3" regimen):
✓. Refractory to or relapsed after second- or third-line low-intensity AML therapy (eg, LDAC, azacitidine or decitabine):
✓. Subject is eligible for and willing to receive the pre-selected CCR treatment option, according to the investigator's assessment (Note: Subjects with degenerative and toxic encephalopathies, especially after the use of methotrexate or treatment with ionizing radiation, should not receive cytarabine.)
✓. Subject has Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 (Appendix D)
Exclusion criteria
✕. Subject is suspected or proven to have acute promyelocytic leukemia based on morphology, immunophenotype, molecular assay, or karyotype
What they're measuring
1
Overall Survival (OS)
Timeframe: From randomization to death due to any cause (up to approximately 49 months)
✕. Subject has AML secondary to chronic myelogenous leukemia
✕. Subject has received a targeted agent against an IDH2 mutation
✕. Subject has received systemic anticancer therapy or radiotherapy \< 14 days prior to the start of study treatment. Note that hydroxyurea is allowed prior to the start of study treatment for the control of leukocytosis (however, hydroxyurea should not be given within 72 hours prior to and after administration of azacitidine).
✕. Subject has received non-cytotoxic or investigational agents \< 14 days or 5 half-lives, whichever is longer, prior to the start of study treatment
✕. Subject has undergone HSCT within 60 days prior to the start of study treatment, or on immunosuppressive therapy post HSCT at the time of screening, or with clinically significant graft-versus-host disease (GVHD). The use of a stable dose of oral steroid post-HSCT and/or topical steroids for ongoing skin GVHD is permitted.
✕. Subject has persistent, clinically significant non-hematologic toxicities from prior therapies
✕. Subject has or is suspected of having central nervous system (CNS) leukemia. Evaluation of cerebrospinal fluid is only required if CNS involvement by leukemia is suspected during screening.