Find a Trial
Trial Summary
| Protocol No. | ARO-021 | ||
|---|---|---|---|
| Status | OPEN TO ACCRUAL | ||
| Principal Investigator | Sayar, Hamid | ||
| Scope | National | ||
| Phase | Phase III | ||
| Age Group | Adult | ||
| Title | Phase III Randomized Study of Crenolanib versus Midostaurin Administered Following Induction Chemotherapy and Consolidation Therapy in Newly Diagnosed Subjects with FLT3 Mutated Acute Myeloid Leukemia | ||
| Description | A phase III randomized multi-center study designed to compare the efficacy of crenolanib with that of midostaurin when administered following induction chemotherapy, consolidation chemotherapy and bone marrow transplantation in newly diagnosed AML subjects with FLT3 mutation. About 510 subjects will be randomized in a 1:1 ratio to receive either crenolanib in addition to standard first line treatment of AML (chemotherapy and if eligible, transplantation) (arm A) or midostaurin and standard treatment (arm B). Potentially eligible subjects will be registered and tested for the presence of FLT3 mutation. Once the FLT3 mutation status is confirmed and additional eligibility is established, subject will be randomized and enter into the treatment phase. | ||
| Key Eligibility | In order to be eligible to take part in this trial, patients must meet the following criteria:
| ||
| Applicable Disease Sites | Myeloid and Monocytic Leukemia | ||
| Participating Institutions | Indiana University (IU) | ||
| Treatment Type | Treatment | ||
| Contact | Phone: (317) 278-5632 Email: iutrials@iu.edu | ||