Acute Myeloid Leukemia (AML) With Clinical Trial
— AMLFLT3Official 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.
| NCT number | NCT02624570 |
| Other study ID # | CPKC412AUS56X |
| Secondary ID | |
| Status | No longer available |
| Phase | |
| First received | |
| Last updated |
| Verified date | July 2020 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Expanded Access |
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.
| Status | No longer available |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Augusta University Georgia Cancer Center Pharmacy | Augusta | Georgia |
| United States | Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans | Beech Grove | Indiana |
| United States | The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr | Berkeley | California |
| United States | Tufts Medical Center | Boston | Massachusetts |
| United States | Medical University of South Carolina Hematology-Oncology Division | Charleston | South Carolina |
| United States | Erlanger Medical Center Erlanger Health System | Chattanooga | Tennessee |
| United States | Cheyenne Regional Medical Center | Cheyenne | Wyoming |
| United States | Rush University Medical Center Dept.of Rush UniversityMedCtr. | Chicago | Illinois |
| United States | University of Chicago Medical Center | Chicago | Illinois |
| United States | Kaiser Permanente NW Region Kaiser Permanente Northwest | Clackamas | Oregon |
| United States | Kaiser Permanente Northwest Kaiser | Denver | Colorado |
| United States | Henry Ford Hospital SC | Detroit | Michigan |
| United States | Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy | Detroit | Michigan |
| United States | City of Hope National Medical Center Department of Hematology & HCT | Duarte | California |
| United States | Poudre Valley Hospital Poudre Valley Hospital -U of C | Fort Collins | Colorado |
| United States | Ft Wayne Medical Oncology and Hematology Inc | Fort Wayne | Indiana |
| United States | St. Judes Medical Center | Fullerton | California |
| United States | University of Texas Medical Branch University of Texas MB | Galveston | Texas |
| United States | Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute | Hershey | Pennsylvania |
| United States | Memorial Healthcare System Memorial Healthcare System | Hollywood | Florida |
| United States | McGovern Medical School at the University of Texas Health | Houston | Texas |
| United States | Oncology Consultants Oncology Consultants | Houston | Texas |
| United States | Healthcare Partners Medical Group | Las Vegas | Nevada |
| United States | Norton Cancer Institute Norton Cancer Institute | Louisville | Kentucky |
| United States | University of Louisville / James Graham Brown Cancer Center Louisville 529-539 | Louisville | Kentucky |
| United States | Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2) | Murray | Utah |
| United States | Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology | Nashville | Tennessee |
| United States | Ochsner Clinic Foundation | New Orleans | Louisiana |
| United States | Tulane University Medical Center | New Orleans | Louisiana |
| United States | Weill Cornell Medical College NY Presbyterian Hospital | New York | New York |
| United States | Virginia Oncology Associates Virginia Oncology Assoc. (6) | Norfolk | Virginia |
| United States | Nebraska Cancer Specialist/Missouri Valley Cancer Consortium | Omaha | Nebraska |
| United States | University of Calif Irvine Medical Center Family Comp Cancer Cntr | Orange | California |
| United States | UF Health Cancer Center at Orlando Health Orlando Health | Orlando | Florida |
| United States | University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr | Philadelphia | Pennsylvania |
| United States | Mayo Clinic Arizona | Phoenix | Arizona |
| United States | Mayo Clinic Mayo Clinic | Rochester | Minnesota |
| United States | University of Rochester Medical Center Univ of Rochester (7) | Rochester | New York |
| United States | Huntsman Cancer Institute Univ of Utah | Salt Lake City | Utah |
| United States | Methodist Healthcare System | San Antonio | Texas |
| United States | Swedish Cancer Institute Cancer Institute | Seattle | Washington |
| United States | Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison | Seattle | Washington |
| United States | H Lee Moffitt Cancer Center and Research Institute SC - 5 | Tampa | Florida |
| United States | Wenatchee Valley Hospital and Clinics | Wenatchee | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
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