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Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started

Description

Summary

The purpose of this study is to provide access to Midostaurin and gather 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.

Official Title

An Open-label, Multi-center, Expanded Treatment Protocol of Midostaurin (PKC412) in 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.

Details

The purpose of this study is to provide Midostaurin (study drug) treatment to newly diagnosed FLT3 mutated (ITD or TKD) AML adult patients (18 years or older) eligible for standard standard induction (cytarabine + daunorubicin/Idarubicin) and consolidation (cytarabine) chemotherapy.

Keywords

Acute Myeloid Leukemia (AML) With FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD) AML FLT3 ITD TKD acute myeloid leukemia induction consolidation continuation EAP ETP midostaurin PKC412 Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Staurosporine

Eligibility

You can join if…

Open to people ages 18 years and up

Written informed consent must be obtained prior to any screening procedures. Patients must meet all Inclusion Criteria:

  • Patient is able to communicate well with the investigator, to understand and comply with the requirements of the study.
  • Patients must be 18 years of age or older; elderly patients must be fit to receive intensive induction and consolidation chemotherapy
  • Patients must have a documented FLT3 mutation (ITD or TKD)
  • Patients must have an ECOG Performance Status of ≤ 2
  • 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 requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
  • 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.
  • Secondary AML, e.g. patients with antecedent history of treatment for prior malignancy Patients must have the following laboratory values (Direct Bilirubin ≤ 2.5 x ULN,Serum Creatinine ≤ 2.5 x ULN)

You CAN'T join if...

Patients eligible for this study must not meet any of the following criteria:

  • Prior therapy for AML with the following exceptions: (emergency leukapheresis,emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 5 days, cranial RT for CNS leukostasis (one dose only), growth factor/cytokine support)
  • Patients with LVEF less than 45% (by echocardiogram or MUGA) or symptomatic congestive heart failure, Class III or IV according to New York Heart Association (NYHA)classification
  • Patients with any uncontrolled illness, including, but not limited to, acute or chronic pancreatitis or uncontrolled infection
  • QTc >500 msec on screening ECG. History of hypersensitivity to any drugs or metabolites of similar chemical classes as the IMP.
  • Participation in a prior investigational interventional (drug) study with administration of the investigational product within 30 days or 5 half-lives of the investigational product, whichever is longer.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they are using two birth control methods.
  • Sexually active males should not father a child during this study and for upto 5 months following.

Locations

  • University of California San Francisco UCSF Medical Center (64)
    San Francisco, California, 94101, United States
  • The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr
    Berkeley, California, 94705, United States
  • Stanford University Medical Center Dept.of Stanford Cancer Center
    Stanford, California, 94305-5826, United States
  • University of California Davis Cancer Center
    Sacramento, California, 95817, United States
  • University of California at Los Angeles Oncology
    Los Angeles, California, 90095, United States
  • USC Norris Cancer Center UCS Norris Cancer Center (7)
    Los Angeles, California, 90033, United States
  • City of Hope National Medical Center Department of Hematology & HCT
    Duarte, California, 91010, United States
  • The Oncology Institute of Hope and Innovation Instit. of Hope and Innovation
    Whittier, California, 90606, United States
  • St. Judes Medical Center
    Fullerton, California, 92835, United States
  • Coast Hematology Oncology Associates
    Long Beach, California, 90806, United States
  • University of California Irvine Family Comp Cancer Cntr
    Orange, California, 92868, United States
  • Loma Linda University School of Medicine
    Loma Linda, California, 92354, United States
  • Healthcare Partners Medical Group
    Las Vegas, Nevada, 89109, United States

Details

Status
not accepting new patients
Start Date
Sponsor
Novartis Pharmaceuticals
ID
NCT02624570
Study Type
Expanded Access
Last Updated
February 16, 2018
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