Acute Myeloid Leukemia Clinical Trial

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

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

View Full Description

Full Description

For each arm:

The phase I with dose-limiting toxicity (DLT) determination will use 3+3 design.

Phase II total of 52 patients (26 per arm) will be treated at established phase I dose.

Enrollment to be simultaneous to each arm.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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.
FLT3 mutation positive (ITD, TKD or other)
ECOG PS 0-2
Adequate liver and renal function
Negative pregnancy test
Extramedullary leukemia allowed except CNS disease

Exclusion Criteria:

Arm 1 and 2 Exclusion:

<5% blasts in marrow or blood at time of screening
Active HIV, hepatitis B or C
CNS leukemia
Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given
Patient with AML-M3 (APL)
Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

28

Study ID:

NCT02400281

Recruitment Status:

Completed

Sponsor:

Arog Pharmaceuticals, Inc.

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

MD Anderson Cancer Center
Houston Texas, 77030, United States

How clear is this clinincal trial information?

Study is for people with:

Acute Myeloid Leukemia

Phase:

Phase 1

Estimated Enrollment:

28

Study ID:

NCT02400281

Recruitment Status:

Completed

Sponsor:


Arog Pharmaceuticals, Inc.

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.