Overview

Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients

Status:
Completed

Trial end date:
2020-07-15

Target enrollment:
0

Participant gender:
All

Summary

This is an open label, two-arm, Phase I-II trial, non-randomized. Arm 1: crenolanib with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin) Arm 2: crenolanib with 5-azacitidine

Phase:

Phase 1/Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Arog Pharmaceuticals, Inc.

Treatments:

Azacitidine
Crenolanib
Cytarabine
Etoposide
Etoposide phosphate
Fludarabine
Fludarabine phosphate
Idarubicin
Mitoxantrone
Vidarabine

Criteria

Inclusion Criteria:

1. Confirmed diagnosis of refractory/relapsed AML or high-risk MDS

- Arm 1: Subjects must have received at least one prior therapy and a maximum of
three prior therapies

- Arm 2: Subjects must have received at least one prior therapy and a maximum of
three prior therapies. No prior treatment with 5-Azacitidine is allowed in this
arm.

2. FLT3 mutation positive (ITD, TKD or other)

3. ECOG PS 0-2

4. Adequate liver and renal function

5. Negative pregnancy test

6. Extramedullary leukemia allowed except CNS disease

Exclusion Criteria:

- Arm 1 and 2 Exclusion:

1. <5% blasts in marrow or blood at time of screening

2. Active HIV, hepatitis B or C

3. CNS leukemia

4. Clinically significant GVHD or organ dysfunction where chemotherapy specified by
protocol cannot be given

5. Patient with AML-M3 (APL)

6. Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C,
nonalcoholic steatohepatitis, sclerosing cholangitis)