2023-03-13
notable
Active, Not Recruiting→Recruiting Study Status, Contacts/Locations v18
Trial statusActive, Not Recruiting→Recruiting
Primary completion date2023-02-28→2025-02-28
Completion date2023-02-28→2025-02-28
Study sitesdetails revised at 3 of 3 sites
2021-10-05
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v15
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 3 of 3 sites
2019-07-16
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations, References v9
Primary completion date2022-01→2022-02-28
Completion date2022-01→2023-02-28
Start date2018-01-07→2018-01-17
Study sites6→3
InterventionsAzacitidine (Drug), Enasidenib (Drug)→Azacitidine (Drug), Enasidenib (Drug), Quality-of-Life Assessment (Other)
Eligibility criteria+157 characters
Inclusion Criteria:
Signed, informed consent must be obtained prior to any study specific procedures.
Subjects must be >/= 12 years of age at the time of informed consent
Subjects with a histologically confirmed diagnosis of MDS, including both MDS and refractory anemia with excess blasts in transformation (RAEB-T) (acute myeloid leukemia [AML] with 20-30% blasts and multilineage dysplasia by French-American-British [FAB] criteria) by World Health Organization (WHO), and chronic myelomonocytic leukemia (CMML) are eligible.
Subjects must have an IDH2 gene mutation (IDH2-R140 or R172) as determi [...] [...]
Secondary endpoints4 to 5 entries
EvaluationEvent-free ofsurvival Molecular and Cellular Markers That May be Predictive of Antitumor Activity(EFS)
Overall Survivalsurvival (OS)
EventAnti-Freetumor Survivalactivity
DurationPharmadynamics of(PDn) Responsemarkers
Drug exposure levels
Primary endpoints2 entries, revised
AdverseIncidence Eventsof adverse events
EfficacyOverall determinedresponse by clinical activity assessed based on Modified IWG Response Criteria for MDSrate
Study description-2,803 characters
Study Groups:
If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on the status of your disease and the treatment you may have received in the past.
If you have never received a hypomethylating drug (such as azacitidine or decitabine), you wi [...] PRIMARY OBJECTIVES:
I. To determine the safety and tolerability of enasidenib alone, and enasidenib in combination with azacitidine (AZA), for patients with isocitrate dehydrogenase 2 (IDH2) mutated myelodysplastic syndrome (MDS).
II.
To assess the efficacy of the combination of enasidenib + azaciti [...]
Collaborators1 to 2 entries
National Cancer Institute (NCI)
Study title-21 characters
TargetedAzacitidine Therapy With the IDH2-Inhibitorand Enasidenib (AG221)in forTreating High-RiskPatients With IDH2-Mutant Myelodysplastic Syndrome
2018-07-12
minor
Study Identification, Study Status, Contacts/Locations v3
Study sitescontacts updated at 1 of 6 sites
2018-03-06
minor
Study Status, Study Description, Eligibility v2
Completion date2022-01→2023-01
Study description+333 characters
[...] u will receive azacitidine by vein over about 30-60 minutes or as an injection under the skin on Days 1-7 of every cycle.
If needed, you may be given azacitidine as an injection under the skin.
If you are receiving azacitidine at a clinic that closes over the weekend, alternate dosing schedules (such as receiving azacitidine on Days 1-5 and 8-9 of each cycle) are possible.
All participants will take enasidenib tablets by mouth with [...] ly, blood (about 2 tablespoons) will be drawn for PK testing before your dose of study drug.
During Cycle 2, blood will also be drawn 4 times over the 8 hours after [...] [...]
2018-01-17
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2022-02→2022-01
Completion date2022-02→2022-01
Start dateestimated 2018-02→confirmed 2018-01-07
Study sitesdetails revised at 6 of 6 sites