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

NCT02624570 | Unknown

• 1 other identifier: CPKC412AUS56X
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 44

Brief 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.

Conditions

Acute Myeloid Leukemia (AML) With; FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)

Keywords

AML; FLT3; ITD; TKD; acute myeloid leukemia; induction; consolidation; continuation; EAP; ETP; midostaurin; PKC412

Interventions

Midostaurin DRUG

Midostaurin, also known as PKC412 is a multi-kinase inhibitor of FLT3 (fms-like tyrosine kinase-3)

Also known as: PKC412

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (44)

Mayo Clinic Arizona

Phoenix, Arizona, 85054, United States

Location

The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr

Berkeley, California, 94705, United States

Location

City of Hope National Medical Center Department of Hematology & HCT

Duarte, California, 91010, United States

Location

St. Judes Medical Center

Fullerton, California, 92835, United States

Location

University of Calif Irvine Medical Center Family Comp Cancer Cntr

Orange, California, 92868, United States

Location

Kaiser Permanente Northwest Kaiser

Denver, Colorado, 80209, United States

Location

Poudre Valley Hospital Poudre Valley Hospital -U of C

Fort Collins, Colorado, 80528, United States

Location

Memorial Healthcare System Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

UF Health Cancer Center at Orlando Health Orlando Health

Orlando, Florida, 32806, United States

Location

H Lee Moffitt Cancer Center and Research Institute SC - 5

Tampa, Florida, 33612, United States

Location

Augusta University Georgia Cancer Center Pharmacy

Augusta, Georgia, 30912, United States

Location

Rush University Medical Center Dept.of Rush UniversityMedCtr.

Chicago, Illinois, 60612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans

Beech Grove, Indiana, 46107, United States

Location

Ft Wayne Medical Oncology and Hematology Inc

Fort Wayne, Indiana, 46815, United States

Location

Norton Cancer Institute Norton Cancer Institute

Louisville, Kentucky, 40202, United States

Location

University of Louisville / James Graham Brown Cancer Center Louisville 529-539

Louisville, Kentucky, 40202, United States

Location

Tulane University Medical Center

New Orleans, Louisiana, 70112, United States

Location

Ochsner Clinic Foundation

New Orleans, Louisiana, 70121, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy

Detroit, Michigan, 48201, United States

Location

Henry Ford Hospital SC

Detroit, Michigan, 48202-2689, United States

Location

Mayo Clinic Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Nebraska Cancer Specialist/Missouri Valley Cancer Consortium

Omaha, Nebraska, 68106, United States

Location

Healthcare Partners Medical Group

Las Vegas, Nevada, 89109, United States

Location

Weill Cornell Medical College NY Presbyterian Hospital

New York, New York, 10021, United States

Location

University of Rochester Medical Center Univ of Rochester (7)

Rochester, New York, 14642, United States

Location

Kaiser Permanente NW Region Kaiser Permanente Northwest

Clackamas, Oregon, 97015, United States

Location

Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute

Hershey, Pennsylvania, 17033-085, United States

Location

University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr

Philadelphia, Pennsylvania, 19104 4283, United States

Location

Medical University of South Carolina Hematology-Oncology Division

Charleston, South Carolina, 29425, United States

Location

Erlanger Medical Center Erlanger Health System

Chattanooga, Tennessee, 37403, United States

Location

Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology

Nashville, Tennessee, 37212, United States

Location

University of Texas Medical Branch University of Texas MB

Galveston, Texas, 77555-1188, United States

Location

McGovern Medical School at the University of Texas Health

Houston, Texas, 77004, United States

Location

Oncology Consultants Oncology Consultants

Houston, Texas, 77024, United States

Location

Methodist Healthcare System

San Antonio, Texas, 78229, United States

Location

Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2)

Murray, Utah, 84107, United States

Location

Huntsman Cancer Institute Univ of Utah

Salt Lake City, Utah, 84112 0550, United States

Location

Virginia Oncology Associates Virginia Oncology Assoc. (6)

Norfolk, Virginia, 23502, United States

Location

Swedish Cancer Institute Cancer Institute

Seattle, Washington, 98104, United States

Location

Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison

Seattle, Washington, 98108, United States

Location

Wenatchee Valley Hospital and Clinics

Wenatchee, Washington, 98801, United States

Location

Cheyenne Regional Medical Center

Cheyenne, Wyoming, 82001, United States

Location

Related Publications (1)

• Roboz GJ, Strickland SA, Litzow MR, Dalovisio A, Perl AE, Bonifacio G, Haines K, Barbera A, Purkayastha D, Sweet K. Updated safety of midostaurin plus chemotherapy in newly diagnosed FLT3 mutation-positive acute myeloid leukemia: the RADIUS-X expanded access program. Leuk Lymphoma. 2020 Dec;61(13):3146-3153. doi: 10.1080/10428194.2020.1805109. Epub 2020 Aug 19.

  PMID: 32812818 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

midostaurin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: December 8, 2015
• Last Updated: July 15, 2020

Record last verified: 2020-07

Locations

US (44)