EUCTR2011-002567-17-DE
Active, not recruiting
Phase 1
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 - MIDOKIT
ConditionsPatients with newly diagnosed c-KIT or FLT3-ITD mutated t(821) AMLMedDRA version: 21.1 Level: LLT Classification code 10060557 Term: Acute myelocytic leukemia System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
DrugsRydapt
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Patients with newly diagnosed c-KIT or FLT3-ITD mutated t(8
- Sponsor
- Technische Universität Dresden
- Enrollment
- 18
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of c\-KIT and/or FLT3\-ITD mutated t(8;21\) AML i.e.
- •o \>20% myeloid blasts in bone marrow and/or peripheral blood at initial diagnosis
- •o Plus cytogenetic diagnosis of aberration t(8;21\)/AML1\-ETO
- •o Plus mutation of c\-KIT gene (mut\-KIT17 or mut\-KIT8\) or FLT3\-ITD mutation or both c\-KIT and FLT3\-ITD mutations
- •Chemo\-responsive disease\* as determined by early bone marrow assessment on day 14\-16 after first cycle of standard induction therapy with seven\-day continuous infusion of 100\-200 mg/m2 cytarabine per day in combination with three doses of daunorubicine, or idarubicine, or mitoxantrone
- •Age 18 – 65 years
- •Fit for intensive chemotherapy as assessed by
- •o Adequate liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:
- •? Total bilirubin \= 1\.5 times the upper limit of normal
- •? ALT and AST \= 2\.5 times upper limit of normal
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 as defined by left ventricular ejection fraction (LVEF) of \=50% as assessed by transthoracal twodimensional echocardiography (M Mode”) or MUGA scan
- •\- Subject without legal capacity who is unable to understand the nature, significance and consequences of the study
- •\- Investigational drug therapy outside of this trial during or within 4 weeks of study entry
- •\- Known or persistent abuse of medication, drugs or alcohol
Outcomes
Primary Outcomes
Not specified
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