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

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

No longer available

CT.gov ID

NCT02624570

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia (AML) With FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)	Drug: Midostaurin

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 Design

Study Type:

Expanded Access

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.

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

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