Description:
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.
Title
- Brief Title: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
- Official Title: Phase III Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy of the Addition of Crenolanib to Salvage Chemotherapy Versus Salvage Chemotherapy Alone in Subjects ≤ 75 Years of Age With Relapsed/Refractory FLT3 Mutated Acute Myeloid Leukemia
Clinical Trial IDs
- ORG STUDY ID:
ARO-013
- SECONDARY ID:
2017-001600-29
- NCT ID:
NCT03250338
Conditions
- Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations
Interventions
Drug | Synonyms | Arms |
---|
Crenolanib | Crenolanib besylate | Crenolanib |
Cytarabine | | Crenolanib |
Mitoxantrone | | Crenolanib |
Placebo Oral Tablet | | Placebo |
Fludarabine | | Crenolanib |
Idarubicin | | Crenolanib |
G-CSF | | Crenolanib |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Crenolanib | Experimental | Crenolanib following salvage chemotherapy | - Crenolanib
- Cytarabine
- Mitoxantrone
- Fludarabine
- Idarubicin
- G-CSF
|
Placebo | Placebo Comparator | Placebo following salvage chemotherapy | - Cytarabine
- Mitoxantrone
- Placebo Oral Tablet
- Fludarabine
- Idarubicin
- G-CSF
|
Eligibility Criteria
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.
Maximum Eligible Age: | 75 Years |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Event-free survival (EFS) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Overall Survival |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Relapse-free Survival (RFS) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | Complete remission rate (CR) |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Measure: | MRD negative complete remission rate |
Time Frame: | 3 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Arog Pharmaceuticals, Inc. |
Last Updated
April 30, 2021