Informationen und Ansprechpartner zu AG-221-AML-005
| Studienbeschreibung |
| AML | AG-221-AML-005 |
| Studientitel | A Phase IB/II, Multicenter, Open-Label Combination Dose-Escalation Safety,
Pharmacokinetic, and Clinical Activity Study of Orally Administered AG-120
or AG-221 and Azacitidine with a Phase II Randomized Expansion
Comparing the Efficacy and Safety of AG-120 or AG-221 and Azacitidine vs.
Azacitidine Alone in Subjects with Untreated Acute Myeloid Leukemia with
an IDH1 or IDH2 Mutation who are not Considered Candidates to Receive
Intensive Chemotherapy (IC) |
| Kurzbeschreibung | This Phase 1b/2 study is an open-label, randomized, multicenter trial to
evaluate the safety and efficacy of oral AG-120 + SC azacitidine and oral A-
221 + Subcutaneous (SC) azacitidine in subjects with newly diagnosed Acute
myeloid leukemia (AML) harboring an Isocitrate dehydrogenase 1 (IDH1) or
an Isocitrate dehydrogenase 2 (IDH2) mutation, respectively. The study
population consists of subjects who are not candidates to receive intensive
IC. The study comprises a Phase 1b dose-escalation stage and a Phase 2
randomized stage. |
| Betreffendes Organsystem | Leukämien/Lymphome
(Hodgkin-Lymphom, Non-Hodgkin-Lymphom, Akute Leukämie, Chronische Leukämie, Multiples Myelom/Plasmozytom, Myelodysplastisches Syndrom, Myeloproliferatives Syndrom) |
| Gesamte Studienbeschreibung | https://clinicaltrials.gov/ct2/show/NCT02677922 |
| Studientyp | Therapie-Studie |
| Studienstatus | Rekrutierung offen (Teilnehmer werden aufgenommen) |
Für weitere Informationen - auch zu den Ein-/Auschlusskriterien - wenden Sie sich bitte an die oben genannten Ansprechpartner im Studienzentrum.
