Clinical trial · Interventional
Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia
A Pilot Study of Daunorubicin-cytarabine Liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) as Induction Therapy for Patients With FLT3 Mutated Acute Myeloid Leukemia Followed by Consolidation With a CD34+-Selected Allograft
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Could not accrue
Summary
Brief summary (as posted)
This is a pilot study designed to identify the effect of daunorubicin-cytarabine liposome (CPX-351) in combination with a FLT3-inhibitor (midostaurin) as induction and consolidation therapy for patients with high-risk FLT3 mutated acute myeloid leukemia (AML) and subsequent CD34+-selected allogeneic stem cell transplant from HLA compatible related or unrelated donors.
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 (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan | Drug | Busulfan | ALIAS |
| CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor | Biological | — | UNRESOLVED |
| CPX-351 | Drug | — | UNRESOLVED |
| Fludarabine | Drug | Fludarabine | ALIAS |
| Melphalan | Drug | Melphalan | ALIAS |
| Midostaurin | Drug | Midostaurin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Investigational Treatment
- description
- Daunorubicin-cytarabine liposome (CPX-351) Plus FLT3-inhibitor (Midostaurin) Induction Therapy followed by Busulfan/Melphalan/Fludarabine Conditioning therapy and CD34+-selected allografts.
- interventionNames
- Drug: CPX-351
- Drug: Midostaurin
- Drug: Busulfan
- Drug: Melphalan
- Drug: Fludarabine
- Biological: CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor
Primary outcomes (3)
- measure
- Change in the complete remission rate
- timeFrame
- 3, 6, 12 and 24 months
- description
- Assess the complete remission rate following induction therapy with CPX-351 plus midostaurin when administered to patients
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a Karnofsky (adult) Performance Status of at least 70%. * Patients must have adequate organ function Exclusion Criteria: * Female patients who are pregnant or breast-feeding * Active viral, bacterial or fungal infection * Patient seropositive for Human Immunodeficiency Virus (HIV-I /II); Human T-Cell Lymphotrophic Virus (HTLV -I /II) * Presence of leukemia in the Central Nervous System (CNS).
References
Publications (0)
Data not yet available