- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03114228
An Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML)
An Open-labeled, Multi-Center, Expanded Treatment Protocol (ETP) of Midostaurin (PKC412) in Patients 18 Years of Age or Older With Newly-diagnosed FLT3-mutated Acute Myeloid Leukemia (AML) Who Are Eligible for Standard Induction and Consolidation Chemotherapy
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Expanded Access Type
- Intermediate-size Population
Contacts and Locations
Study Locations
-
-
Ontario
-
Hamilton, Ontario, Canada, L8V 1C3
- Novartis Investigative Site
-
-
Quebec
-
Montreal, Quebec, Canada, H1T 2M4
- Novartis Investigative Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Written informed consent must be obtained prior to any screening procedures.
- 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 with secondary AML are eligible, e.g. patients with antecedent history of treatment for prior malignancy. 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.
- Patients must have a documented FLT3 mutation (ITD or TKD)
- Patients must be 18 years of age or older; elderly patients must be fit to receive intensive induction and consolidation chemotherapy
- Patients must enroll prior to completion of cycle 2 of the consolidation chemotherapy.
- Patients must have an ECOG Performance Status of ≤ 2
- Patients requiring intrathecal chemotherapy must have a minimum washout of 48 hours prior to the first dose of midostaurin
Patients must have the following laboratory values:
- Total Bilirubin ≤ 2.5 x ULN
- Serum Creatinine ≤ 2.5 x ULN Exclusion Criteria
1. Prior therapy for AML with the following exceptions:
- emergency leukapheresis
- emergency treatment for hyperleukocytosis with hydroxyurea for ≤ 7 days
- cranial RT for CNS leukostasis (one dose only)
growth factor/cytokine support 2. 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 3. Patients with any pulmonary infiltrate including those suspected to be of infectious origin (unless resolved to < Grade 1 within screening timeframe) 4. Patients with any uncontrolled illness, including, but not limited to, acute or chronic pancreatitis or uncontrolled infection 5. QTc >500 msec on screening ECG. 6. History of hypersensitivity to any drugs or metabolites of similar chemical classes as the study treatment. 7. 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. 8. Pregnancy statements and contraception requirements: Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 3 months after stopping medication. Highly effective contraception methods include:
- Total abstinence (when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
- Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that subject
- Use of oral, injected or implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS), or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CPKC412A2001X
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.
Clinical Trials on FLT3-mutated Acute Myeloid Leukemia
-
Arog Pharmaceuticals, Inc.WithdrawnRelapsed/Refractory FLT3-mutated AML
-
Astellas Pharma IncActive, not recruitingAcute Myeloid Leukemia | FLT3-mutated Acute Myeloid LeukemiaJapan, Korea, Republic of, Taiwan
-
M.D. Anderson Cancer CenterAriad PharmaceuticalsWithdrawnLeukemia | FLT3-Mutated Acute Myeloid Leukemia | FLT3-Mutated High-Risk Myelodysplastic Syndrome
-
Novartis PharmaceuticalsRecruitingFLT3-mutated Acute Myeloid LeukemiaKorea, Republic of, Germany, Italy, Turkey, Czechia, Jordan, Slovenia, Austria, Poland, Japan, Russian Federation, United States, Greece
-
Astellas Pharma Global Development, Inc.RecruitingAcute Myeloid Leukemia (AML) | FLT3-mutated Acute Myeloid LeukemiaUnited States
-
French Innovative Leukemia OrganisationAcute Leukemia French AssociationRecruitingAML, Adult | Relapsed Adult AML | Refractory AML | FLT3-TKD Mutation | FLT3-ITDFrance
-
Mayo ClinicNational Cancer Institute (NCI)TerminatedSecondary Acute Myeloid Leukemia | Untreated Adult Acute Myeloid Leukemia | Acute Myeloid Leukemia With FLT3/ITD Mutation | Acute Myeloid Leukemia With Gene Mutations | FLT3 Tyrosine Kinase Domain Point MutationUnited States
-
French Innovative Leukemia OrganisationAcute Leukemia French AssociationCompletedRelapsed Adult AML | Refractory AML | FLT3-TKD Mutation | FLT3-ITDFrance
-
Gruppo Italiano Malattie EMatologiche dell'AdultoRecruitingAcute Myeloid Leukemia With FLT3/ITD MutationItaly
-
Kronos BioTerminatedNucleophosmin 1-mutated Acute Myeloid LeukemiaIsrael, Spain, France, United States, Czechia, Hungary, Korea, Republic of, Germany, Italy, Poland, Brazil, Canada
Clinical Trials on Midostaurin
-
University Medical Center GroningenUnknown
-
Novartis PharmaceuticalsAvailableAcute Myeloid Leukemia | Mast Cell Leukemia | Aggressive Systemic Mastocytosis | Systemic Mastocytosis With an Associated Hematologic Neoplasm | FMS-Like Tyrosine Kinase 3 (FLT3)-Mutated Acute Myeloid Leukemia
-
Novartis PharmaceuticalsCompletedAML and High Risk MDSGermany, Italy, France, Netherlands, United States, Australia, Japan
-
Novartis PharmaceuticalsCompletedLeukemiaUnited States, Belgium, Netherlands, Canada, Austria, Germany, Australia, United Kingdom, Turkey, France, Poland, Norway
-
Novartis PharmaceuticalsTerminatedAcute Myeloid Leukemia | Acute Lymphoblastic LeukemiaSweden, Italy, France, United States, Netherlands
-
Technische Universität DresdenNovartis PharmaceuticalsCompletedAcute Myeloid LeukemiaGermany
-
University of KansasNovartisCompletedAcute Myeloid LeukemiaUnited States
-
Technische Universität DresdenPfizer; Novartis PharmaceuticalsRecruiting
-
Richard Stone, MDMassachusetts General Hospital; Novartis; Beth Israel Deaconess Medical Center; Brigham and Women's HospitalActive, not recruitingRAD001 in Combination With PKC412 in Patients With Relapsed, Refractory or Poor Prognosis AML or MDSAcute Myeloid Leukemia | Myelodysplastic SyndromeUnited States
-
Massachusetts General HospitalCompleted