Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Conditions
Brief summary
This is a randomized, multi-center, double-blind, placebo-controlled study designed to evaluate the efficacy of crenolanib administered following salvage chemotherapy, consolidation chemotherapy, post bone marrow transplantation and as maintenance in relapsed/refractory AML subjects with FLT3 activating mutation.
Interventions
DRUGCrenolanib
Crenolanib will be administered orally
DRUGCytarabine
HAM regimen FLAG-Ida
DRUGMitoxantrone
HAM regimen
DRUGPlacebo Oral Tablet
Placebo will be administered orally
DRUGFludarabine
FLAG-Ida regimen
DRUGIdarubicin
FLAG-Ida regimen
DRUGG-CSF
FLAG-Ida regimen
Sponsors
Arog Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification 2. Presence of FLT3-ITD and/or D835 mutation(s) 3. Subjects must be primary refractory or relapsed to 1st line intensive treatment for AML or refractory or relapsed after second line of treatment for AML 4. Age ≥ 18 years and ≤ 75 years 5. Adequate hepatic function 6. Adequate renal functions 7. ECOG performance status ≤ 3
Exclusion criteria
1. Known clinically active central nervous system(CNS) leukemia 2. Severe liver disease 3. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) 4. Prior anti-leukemia therapy within the 14 days prior to randomization. Prior use of quizartinib or gilteritinib must be discontinued 21 days prior to randomization. Prior use of hydroxyurea or other palliative treatment for leukocytosis is allowed. 5. Previous treatment with crenolanib or prior participation in clinical trial involving crenolanib.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free survival (EFS) | 3 years |
Secondary
| Measure | Time frame |
|---|---|
| Overall Survival | 3 years |
| Relapse-free Survival (RFS) | 3 years |
| Complete remission rate (CR) | 3 years |
| MRD negative complete remission rate | 3 years |
Countries
Canada, France, Germany, Italy, Spain, United States
Contacts
PRINCIPAL_INVESTIGATOREunice Wang, MD
Roswell Park Cancer Institute, Buffalo, New York, United States, 14263
Outcome results
None listed