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Clinical trial

Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Combination With Standard Chemotherapy During Induction and Consolidation Followed by 12 Months of Monotherapy in Patients With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia.

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Last updated:13th Feb 2018
Identifier: NCT03379727

The purpose of this study is to gather and evaluate additional safety and efficacy data on the combination of midostaurin and standard of care for adult patients with newly diagnosed Fms-like tyrosine kinase receptor (FLT3) mutated Acute Myeloid Leukemia (AML) who are eligible for standard induction and consolidation


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 300 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Considering the limited safety impact and the significant clinical benefit of the addition of midostaurin to the standard "7+3" regimen in the RATIFY study (CPKC412A2301), this Phase IIIb study is designed as a single arm study and allows the assessment of variation of the "7+3" regimen in an extended patient population compared to RATIFY (higher dose of daunorubicin (60-90 mg/m2/day), the substitution of daunorubicin by idarubicin (12mg/m2/day), and lower dose of cytarabine (100-200 mg/m2/day) and the "5+2" reduced dose regimen). Safety is the primary endpoint. CR/CRi (see Section 7.2.1) in induction, consolidation and maintenance therapy is collected as secondary endpoint.

Patients who are newly diagnosed with AML, have a known FLT3 ITD or TKD, mutation and have recently started on "7+3" or "5+2" in induction and high dose of cytarabine in consolidation will be consented and screened for the clinical study.
Number of Arms: 1

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multi-Center, Phase IIIb Study to Assess the Safety and Efficacy of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia Who Are Eligible for "7+3" or "5+2" Chemotherapy
Actual Study Start Date: February 13, 2018
Estimated Primary Completion Date: December 14, 2021
Estimated Study Completion Date: December 15, 2021

Arm:
- Experimental:
Midostaurin

Category Value
Date last updated at source 2019-05-01
Study type(s) Interventional
Expected enrolment 300
Study start date 2018-02-13
Estimated primary completion date 2021-12-14

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