A phase 3 randomized, double-blind study of induction (Daunorubicin/Cytarabine) and consolidation (high-dose Cytarabine) chemotherapy + Midostaurin (PKC412) (IND# 101261) or placebo in newly diagnosed patients < 60 years of age with FLT3 mutated Acute Myeloid Leukemia (AML)

Phase 3

Recruiting

• Conditions: Acute Myeloid Leukemia; cancer of the bone marrow; 10024324

• Registration Number: NL-OMON32771
• Lead Sponsor: ovartis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

*Unequivocal diagnosis of AML (>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia).
*Documented FLT3 mutation (ITD or point mutation), determined by analysis in a protocol-designed FLT3 screening laboratory.
*Age greater than or equal to 18 years and less than 60 years.
*AML patients with a history of antecedent myelodyspasia (MDS) remain eligible for treatment on this trial, but must not have had prior cytotoxic therapy (e.g. azacitidine or decitabine).
*Bilirubin < 2.5 times upper limit of normal.

Exclusion Criteria

*No prior chemotherapy for leukemia or myelodysplasia with the following exceptions:
i. emergency leukapheresis
ii. emergency treatment for hyperleukocytosis with hydroxyurea for less than or equal to 5 days
iii. cranial RT for CNS leukostasis (one dose only)
iv. growth factor/cytokine support
*Patients who have developed therapy related AML after prior RT or chemotherapy for another cancer or disorder are not eligible.
*Patients with symptomatic congestive heart failure are not eligible.
*Pregnant or nursing patients may not be enrolled

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Overall survival (OS) in the mutant AML FLT3-ITD and the FLT3-TKD patients is<br /><br>the primary endpoint. The OS time is the period from the date of registration<br /><br>in the study until death by any cause.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Four secondary endpoints will be analyzed in this study:<br /><br>1) Complete response (CR) rate in the remission induction stage of the study<br /><br>2) event- free survival (EFS)<br /><br>3) disease- free survival (DFS)<br /><br>4) the DFS rate one year after completing the planned continuation phase</p><br>