An Open-labeled, Multi-Center, Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) Who Are Eligible for Standard Induction and Consolidation Chemotherapy

Novartis Pharmaceuticals1 site in 1 countryApril 14, 2017

ConditionsFLT3-mutated Acute Myeloid Leukemia

DrugsMidostaurin

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: FLT3-mutated Acute Myeloid Leukemia
Sponsor: Novartis Pharmaceuticals
Locations: 1
Status: No Longer Available
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to gather and evaluate additional safety 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 chemotherapy and are without satisfactory treatment alternatives prior to the commercial availability* and reimbursement of midostaurin during the regulatory approval process

Registry

clinicaltrials.gov

Start Date

April 14, 2017

End Date

TBD

Last Updated

6 years ago

Study Type

Expanded Access

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Written informed consent must be obtained prior to any screening procedures.
•Patients must have a documented unequivocal diagnosis of AML according to WHO 2008 classification (≥20% blasts in the bone marrow and/or peripheral blood), excluding M3 (acute promyelocytic leukemia). Patients with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. AML patients with a history of antecedent treatment for myelodysplasia (MDS), e.g. azacitidine or decitabine, remain eligible for treatment on this study. These agents must have been discontinued for a period of at least 30 days or 5 half-lives of the drug (whichever is greater) before midostaurin can be administered.
•Patients must have a documented FLT3 mutation (ITD or TKD)
•Patients must be 18 years of age or older; elderly patients must be fit to receive intensive induction and consolidation chemotherapy
•Patients must enroll prior to completion of cycle 2 of the consolidation chemotherapy.
•Patients must have an ECOG Performance Status of ≤ 2
•Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
•Patients must have the following laboratory values:
•Total Bilirubin ≤ 2.5 x ULN
•Serum Creatinine ≤ 2.5 x ULN Exclusion Criteria