Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy (AMLFLT3)

July 14, 2020 updated by: Novartis Pharmaceuticals

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
No longer available

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Expanded Access

Expanded Access Type

Expanded Access Type

Describes the category of expanded access under U.S. Food and Drug Administration (FDA) regulations. There are three types of expanded access:
  • Individual Patients: Allows a single patient, with a serious disease or condition who cannot participate in a clinical trial, access to a drug or biological product that has not been approved by the FDA. This category also includes access in an emergency situation.
  • Intermediate-size Population: Allows more than one patient (but generally fewer patients than through a Treatment IND/Protocol) access to a drug or biological product that has not been approved by the FDA. This type of expanded access is used when multiple patients with the same disease or condition seek access to a specific drug or biological product that has not been approved by the FDA.
  • Treatment IND/Protocol: Allows a large, widespread population access to a drug or biological product that has not been approved by the FDA. This type of expanded access can only be provided if the product is already being developed for marketing for the same use as the expanded access use.
  • Treatment IND/Protocol

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Mayo Clinic Arizona
    • California
      • Berkeley, California, United States, 94705
        • The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center Department of Hematology & HCT
      • Fullerton, California, United States, 92835
        • St. Judes Medical Center
      • Orange, California, United States, 92868
        • University of Calif Irvine Medical Center Family Comp Cancer Cntr
    • Colorado
      • Denver, Colorado, United States, 80209
        • Kaiser Permanente Northwest Kaiser
      • Fort Collins, Colorado, United States, 80528
        • Poudre Valley Hospital Poudre Valley Hospital -U of C
    • Florida
      • Hollywood, Florida, United States, 33021
        • Memorial Healthcare System Memorial Healthcare System
      • Orlando, Florida, United States, 32806
        • UF Health Cancer Center at Orlando Health Orlando Health
      • Tampa, Florida, United States, 33612
        • H Lee Moffitt Cancer Center and Research Institute SC - 5
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Augusta University Georgia Cancer Center Pharmacy
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center Dept.of Rush UniversityMedCtr.
    • Indiana
      • Beech Grove, Indiana, United States, 46107
        • Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans
      • Fort Wayne, Indiana, United States, 46815
        • Ft Wayne Medical Oncology and Hematology Inc
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Norton Cancer Institute Norton Cancer Institute
      • Louisville, Kentucky, United States, 40202
        • University of Louisville / James Graham Brown Cancer Center Louisville 529-539
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Clinic Foundation
      • New Orleans, Louisiana, United States, 70112
        • Tulane University Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy
      • Detroit, Michigan, United States, 48202-2689
        • Henry Ford Hospital SC
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Mayo Clinic
    • Nebraska
      • Omaha, Nebraska, United States, 68106
        • Nebraska Cancer Specialist/Missouri Valley Cancer Consortium
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Healthcare Partners Medical Group
    • New York
      • New York, New York, United States, 10021
        • Weill Cornell Medical College NY Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • University of Rochester Medical Center Univ of Rochester (7)
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Kaiser Permanente NW Region Kaiser Permanente Northwest
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033-085
        • Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute
      • Philadelphia, Pennsylvania, United States, 19104 4283
        • University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina Hematology-Oncology Division
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Medical Center Erlanger Health System
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology
    • Texas
      • Galveston, Texas, United States, 77555-1188
        • University of Texas Medical Branch University of Texas MB
      • Houston, Texas, United States, 77024
        • Oncology Consultants Oncology Consultants
      • Houston, Texas, United States, 77004
        • McGovern Medical School at the University of Texas Health
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare System
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2)
      • Salt Lake City, Utah, United States, 84112 0550
        • Huntsman Cancer Institute Univ of Utah
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Virginia Oncology Associates Virginia Oncology Assoc. (6)
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute Cancer Institute
      • Seattle, Washington, United States, 98108
        • Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison
      • Wenatchee, Washington, United States, 98801
        • Wenatchee Valley Hospital and Clinics
    • Wyoming
      • Cheyenne, Wyoming, United States, 82001
        • Cheyenne Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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)

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 3, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2015

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2015

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CPKC412AUS56X

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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