Crenolanib vs Midostaurin for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+30 other locations

Age: 18 - 65

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Arog Pharmaceuticals, Inc.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults aged 18-60 with newly diagnosed Acute Myeloid Leukemia (AML) that has a specific mutation called FLT3. Participants must have good liver and kidney function, not be too sick to undergo intensive chemotherapy, and can't have had previous cancer treatments except hydroxyurea or leukapheresis.

Inclusion Criteria

My cancer has FLT3-ITD or D835 mutations.

I am eligible for a specific intensive chemotherapy treatment.

I have been diagnosed with a new case of AML as per WHO 2016 guidelines.

I am between 18 and 60 years old.

Exclusion Criteria

I have an active hepatitis B or C infection.

I have severe liver disease.

I have active leukemia in my brain or spinal cord.

I do not have any active infections.

I have been diagnosed with acute promyelocytic leukemia.

I am HIV positive.

Participant Groups

The study compares Crenolanib versus Midostaurin effectiveness when given after standard AML treatment: induction chemo, consolidation therapy, and possibly bone marrow transplant. About 510 patients will be randomly assigned to either the Crenolanib group (arm A) or the Midostaurin group (arm B).

2Treatment groups

Experimental Treatment

Active Control

Group I: CrenolanibExperimental Treatment3 Interventions

Crenolanib following salvage chemotherapy

Group II: MidostaurinActive Control3 Interventions

Midostaurin following salvage chemotherapy