Clinical trial · Interventional
Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Crenolanib | Drug | Crenolanib | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
| Placebo Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Crenolanib
- description
- Crenolanib following salvage chemotherapy
- interventionNames
- Drug: Crenolanib
- Drug: Cytarabine
- Drug: Mitoxantrone
- Drug: Fludarabine
- Drug: Idarubicin
- Drug: G-CSF
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo following salvage chemotherapy
- interventionNames
- Drug: Cytarabine
- Drug: Mitoxantrone
- Drug: Placebo Oral Tablet
- Drug: Fludarabine
- Drug: Idarubicin
- Drug: G-CSF
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available