A Phase III Study of Crenolanib or Midostaurin after Induction and Consolidation Chemotherapy for Patients with Newly Diagnosed Acute Myeloid Leukemia

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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

Purpose

Midostaurin is a drug given to patients with acute myeloid leukemia (AML) that contains a genetic mutation in a gene called FLT3. It is used after initial chemotherapy (intensive “induction” chemotherapy and less intensive “consolidation” chemotherapy) and then may be used for up to a year after remission is achieved to keep the leukemia from coming back.

Crenolanib is a newer investigational drug designed to be more selective than midostaurin, targeting FLT3 mutations to specifically reduce or block their activity in cancer cells. Midostaurin has been shown to be effective against many targets, and although it represents an advance in the treatment of FLT3-mutated AML, it may not be as effective as a more targeted drug like crenolanib.

The purpose of this study is to determine if giving crenolanib after chemotherapy may be more effective than giving midostaurin after chemotherapy in patients with FLT3-mutated AML. Patients will be randomly assigned to receive one drug or the other after initial chemotherapy. Both medications are taken orally (by mouth). Initial studies in patients with FLT3-mutated AML showed very promising results when crenolanib was given after chemotherapy, but this is the first time crenolanib has been directly compared to midostaurin.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have newly diagnosed, previously untreated FLT3-mutated AML.
  • Patients must be eligible to receive intensive chemotherapy
  • In addition to patients with good physical function, this study is also open to those who are capable of only limited self-care and are confined to bed or chair for more than half of their normal waking hours.
  • This study is for patients ages 18-60.

For more information about this study and to inquire about eligibility, please contact Dr. Aaron Goldberg at 212-639-2126.

Protocol

18-334

Phase

III

Disease Status

Newly Diagnosed

Investigator

Co-Investigators