Acute Myeloid Leukemia (AML) WithAMLFLT3NCT02624570
Midostaurin Access Program for Newly Diagnosed FLT3 (ITD or TKD) Mutated AML Adult Patients Eligible for Standard Induction and Consolidation Chemotherapy
A study testing Midostaurin in people with Acute Myeloid Leukemia (AML) With and FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD), run by Novartis Pharmaceuticals at 44 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
- What is being tested?
- Midostaurin
- How many people
- Not given
- Where
- 44 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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)
Who cannot join
- 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.
Trial locations and contacts
44 sites in 1 country.
44 sites in 1 country
United States44 sites
Augusta University Georgia Cancer Center Pharmacy
Augusta, Georgia, 30912
Indiana Blood and Marrow Institute Indiana Blood and Marrow Trans
Beech Grove, Indiana, 46107
The Jordan Research and Education Center ABSMC Comprehensive Cancer Ctr
Berkeley, California, 94705
Tufts Medical Center
Boston, Massachusetts, 02111
Medical University of South Carolina Hematology-Oncology Division
Charleston, South Carolina, 29425
Erlanger Medical Center Erlanger Health System
Chattanooga, Tennessee, 37403
Cheyenne Regional Medical Center
Cheyenne, Wyoming, 82001
Rush University Medical Center Dept.of Rush UniversityMedCtr.
Chicago, Illinois, 60612
University of Chicago Medical Center
Chicago, Illinois, 60637
Kaiser Permanente NW Region Kaiser Permanente Northwest
Clackamas, Oregon, 97015
Kaiser Permanente Northwest Kaiser
Denver, Colorado, 80209
Karmanos Cancer Institute Harper Hosp. Invest. Pharmacy
Detroit, Michigan, 48201
Henry Ford Hospital SC
Detroit, Michigan, 48202-2689
City of Hope National Medical Center Department of Hematology & HCT
Duarte, California, 91010
Poudre Valley Hospital Poudre Valley Hospital -U of C
Fort Collins, Colorado, 80528
Ft Wayne Medical Oncology and Hematology Inc
Fort Wayne, Indiana, 46815
St. Judes Medical Center
Fullerton, California, 92835
University of Texas Medical Branch University of Texas MB
Galveston, Texas, 77555-1188
Penn State University / Milton S. Hershey Medical Center Penn State Cancer Institute
Hershey, Pennsylvania, 17033-085
Memorial Healthcare System Memorial Healthcare System
Hollywood, Florida, 33021
McGovern Medical School at the University of Texas Health
Houston, Texas, 77004
Oncology Consultants Oncology Consultants
Houston, Texas, 77024
Healthcare Partners Medical Group
Las Vegas, Nevada, 89109
Norton Cancer Institute Norton Cancer Institute
Louisville, Kentucky, 40202
University of Louisville / James Graham Brown Cancer Center Louisville 529-539
Louisville, Kentucky, 40202
Intermountain Healthcare - Huntsman Cancer Clinics Intermountain Healthcare (2)
Murray, Utah, 84107
Vanderbilt University Medical Center, Clinical Trials Center Division Hematology/Oncology
Nashville, Tennessee, 37212
Tulane University Medical Center
New Orleans, Louisiana, 70112
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
Weill Cornell Medical College NY Presbyterian Hospital
New York, New York, 10021
Virginia Oncology Associates Virginia Oncology Assoc. (6)
Norfolk, Virginia, 23502
Nebraska Cancer Specialist/Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
University of Calif Irvine Medical Center Family Comp Cancer Cntr
Orange, California, 92868
UF Health Cancer Center at Orlando Health Orlando Health
Orlando, Florida, 32806
University of Pennsylvania Cancer Center University of Pen/Abr Canc ctr
Philadelphia, Pennsylvania, 19104 4283
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Mayo Clinic Mayo Clinic
Rochester, Minnesota, 55905
University of Rochester Medical Center Univ of Rochester (7)
Rochester, New York, 14642
Huntsman Cancer Institute Univ of Utah
Salt Lake City, Utah, 84112 0550
Methodist Healthcare System
San Antonio, Texas, 78229
Swedish Cancer Institute Cancer Institute
Seattle, Washington, 98104
Veterans Affairs Puget Sound Health Care System VAMC Seattle, WA Divison
Seattle, Washington, 98108
H Lee Moffitt Cancer Center and Research Institute SC - 5
Tampa, Florida, 33612
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801
About this study
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.
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.
Read the 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.
- Conditions
- Acute Myeloid Leukemia (AML) With, FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD)
- Being tested
- Midostaurin
- Keywords
- AML, FLT3, ITD, TKD, acute myeloid leukemia, induction, consolidation, continuation, EAP, ETP, midostaurin, PKC412
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidostaurinDrug
Also called PKC412
Midostaurin, also known as PKC412 is a multi-kinase inhibitor of FLT3 (fms-like tyrosine kinase-3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myeloid Leukemia (AML) WithStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02624570
- Sponsor's protocol ID
- CPKC412AUS56X
- Acronym
- AMLFLT3
- Status last verified
- Jul 2020
- First submitted
- 3 Dec 2015
- Last updated
- 15 Jul 2020
- Results posted
- No
Publications
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.
PubMed 32812818
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02624570
- Acronym / sponsor ID
- AMLFLT3 / CPKC412AUS56X
- 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
- Study type
- Expanded access
- Recruitment status
- No Longer Available
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- First posted
- 8 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidostaurinAlso: PKC412Midostaurin, also known as PKC412 is a multi-kinase inhibitor of FLT3 (fms-like tyrosine kinase-3) | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Derived from this study: PubMed 32812818Roboz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
44 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midostaurin in people with Acute Myeloid Leukemia (AML) With and FLT3 Mutation, Internal Tandem Duplication (ITD) or Tyrosine Kinase Domain (TKD), run by Novartis Pharmaceuticals at 44 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02624570, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.