Clinical trial · Interventional
Study of Crenolanib Combined With Chemotherapy in FLT3-mutated Acute Myeloid Leukemia Patients
Phase I-II Study of Crenolanib Combined With Standard Salvage Chemotherapy, and Crenolanib Combined With 5-Azacitidine in Acute Myeloid Leukemia Patients With FLT3 Activating Mutations
NCT02400281CI-TRIAL-00078542completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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 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
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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Azacytidine | Drug | Azacitidine | ALIAS |
| Crenolanib besylate | Drug | Crenolanib | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Etoposide | Drug | Etoposide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
| G-CSF | Drug | — | UNRESOLVED |
| Idarubicin | Drug | Idarubicin | ALIAS |
| Mitoxantrone | Drug | Mitoxantrone | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm 1 crenolanib besylate combination
- description
- Arm 1 patients will receive crenolanib besylate, combined with standard chemotherapy (Idarubicin/Cytarabine, MEC;Mitoxantrone/Etoposide/Cytarabine, FLAG-Ida: Fludarabine/Cytarabine/G-CSF/Idarubicin
- interventionNames
- Drug: Crenolanib besylate
- Drug: Idarubicin
- Drug: Cytarabine
- Drug: Mitoxantrone
- Drug: Etoposide
- Drug: Fludarabine
- Drug: G-CSF
- type
- EXPERIMENTAL
- label
- Arm 2 crenolanib besylate combination
- description
- Arm 2 patients will receive crenolanib besylate and azacytidine.
- interventionNames
- Drug: Crenolanib besylate
- Drug: Azacytidine
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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. 2. FLT3 mutation positive (ITD, TKD or other) 3. ECOG PS 0-2 4. Adequate liver and renal function 5. Negative pregnancy test 6. Extramedullary leukemia allowed except CNS disease Exclusion Criteria: * Arm 1 and 2 Exclusion: 1. \<5% blasts in marrow or blood at time of screening 2. Active HIV, hepatitis B or C 3. CNS leukemia 4. Clinically significant GVHD or organ dysfunction where chemotherapy specified by protocol cannot be given 5. Patient with AML-M3 (APL) 6. Pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis B or C, nonalcoholic steatohepatitis, sclerosing cholangitis)
References
Publications (0)
Data not yet available
No reference posted for this study.