Clinical trial · Interventional
Trial to Assess the Efficacy of Midostaurin (PKC412) in Patients With c-KIT or FLT3-ITD Mutated t(8;21) AML
A Single-arm Phase II Trial to Assess the Efficacy of Midostaurin (PKC412) Added to Standard Primary Therapy in Patients With Newly Diagnosed c-KIT or FLT3-ITD Mutated t(8;21) AML
NCT01830361CI-TRIAL-00046478MIDOKITcompletedPhase 2ClinicalTrials.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)
To assess the efficacy of tyrosine-kinase inhibitor midostaurin in c-KIT or FLT3-ITD mutated t(8;21) AML. To assess the efficacy of midostaurin depending on the type of c-KIT 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 |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| midostaurin (PKC412) | Drug | Midostaurin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- midostaurin (PKC412), capsules
- description
- midostaurin 50 mg (two 25 mg capsules) is given in combination with the second of two induction cycles and in combination with three cycles of high-dose cytarabine (HiDAC) consolidation chemotherapies and maintenance treatment in patients with c-kit or FLT3-ITD positive t(8;21) AML in an open-label one-arm design. The first cycle of induction is not part of the study.
- interventionNames
- Drug: midostaurin (PKC412)
Primary outcomes (1)
- measure
- Event-free Survival
- timeFrame
- 2-year Event-free Survival
Secondary outcomes (7)
- measure
- Time to relapse
- timeFrame
- 2-years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of c-KIT mutated t(8;21) AML i.e. 1. \>20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis 2. Plus cytogenetic diagnosis of aberration t(8;21)/AML1-ETO 3. Plus mutation of c-KIT gene (mut-KIT17 or mut-KIT8) or FLT3-ITD mutation or both c-KIT and FLT3-ITD mutations * Chemoresponsive disease as determined by early bone marrow assessment on day 14-16 after first cycle of induction therapy with cytarabine in combination with daunorubicine or idarubicine, or mitoxantrone- Fit for further intensive chemotherapy * Age 18-65 years * ECOG performance status of 0-2 * Life expectancy of at least 12 weeks Exclusion Criteria: * Primary refractory or previously relapsed AML * Non-eligibility for high-dose cytarabine based consolidation, e.g. intolerance to cytarabine * Inability to swallow oral medications * Symptomatic congestive heart failure * Bilirubin \>2.5 x upper limit of normal
References
Publications (0)
Data not yet available
No reference posted for this study.