Phase 2
N=28
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Acute Myeloid Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT02400281 ↗Enrolled (actual)
28
Serious AEs
100.0%
Results posted
Mar 2024
Primary outcome: Primary: Response Rate of Crenolanib Besylate Combination Therapy — 2; 0; 3; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Crenolanib besylate (Drug); Idarubicin (Drug); Cytarabine (Drug); Azacytidine (Drug); Mitoxantrone (Drug); Etoposide (Drug); Fludarabine (Drug); G-CSF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Arog Pharmaceuticals, Inc.
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Response Rate of Crenolanib Besylate Combination Therapy |
2; 0; 3; 1; 1; 0 | — |
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
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)
Data sourced from ClinicalTrials.gov (NCT02400281). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.