Acute Myeloid Leukemia, Adult Clinical Trial
Official title:
Midostaurin in MRD (Minimal Residual Disease) Positive Acute Myeloid Leukemia After Allogeneic Stem Cell Transplantation
Verified date | January 2022 |
Source | University of Jena |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The MAURITIUS trial is a single-arm, multicenter phase II study of single treatment with midostaurin being applied to AML (acute myeloid leukemia) patients with activating FLT3 (FMS-like tyrosine kinase3) mutations and either molecular relapse or persistent molecular positivity after allogeneic SCT. The leukemia-free survival (LFS), the achievement of "MRD low" as well as the incidence of GvHD after transplantation reflect the most relevant endpoints of this non-randomized clinical trial.
Status | Terminated |
Enrollment | 1 |
Est. completion date | February 28, 2021 |
Est. primary completion date | February 28, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients with molecular relapse or persistent molecular positivity of AML after allogeneic SCT (stem cell Transplantation) - Detection of FLT3-ITD (Internal tandem duplication) or FLT3-TKD (tyrosine kinase domain) at primary diagnosis or at antecedent relapse of AML prior to allogeneic SCT - Sensitive MRD assessment based on qPCR (e.g. by means of NPM1 mutations) - absolute neutrophil count > 1,0 Gpt/L and Platelets > 50 Gpt/L - ECOG (Eastern Cooperative Oncology Group) performance status 0-2 - glomerular filtration rate > 30 ml/min and serum bilirubin < 1.5 x upper limit of normal - Serum aspartate transaminase (AST) and/or alanine transaminase (ALT) = 3.0 × ULN - Normal serum levels of potassium, magnesium, and corrected calcium - Written informed consent prior to any study procedures being performed - Age = 18 years Exclusion Criteria: - Acute promyelocytic leukemia (APL) - Hematological relapse of AML - Lack of a suitable MRD marker - Impaired ejection fraction (LVEF) < 45% - Patients with midostaurin treatment after allogeneic SCT or with ongoing TKI therapy < 4 weeks prior to inclusion - Treatment with an investigational drug within 5 half-lives preceding the first dose of study medication - History of acute or chronic pancreatitis - Active and uncontrolled infections - History of severe lung disease and/or relevant functional impairment - Medical indication for treatment with strong CYP3A4 inhibitors (e.g. voriconazole, posaconazole, clarithromycin) - Positive PCR for Human Immunodeficiency Virus (HIV) or Hepatitis B or C - Patients unable to swallow medication - Known hypersensitivity reaction to midostaurin or any excipient of midostaurin - Concomitant medications with known induction of CYP3A4 isoenzyme unless they can be discontinued or replaced prior to enrollment - Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy - Patients who are pregnant or breast feeding, or females of reproductive potential not employing an effective method of birth control. Female patients must agree to an effective birth control throughout the study and for up to 4 months beyond. - Other medical conditions (e.g. corrected QT interval prolongation) that might interfere with midostaurin treatment - Substance abuse, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum Chemnitz gGmbH | Chemnitz | |
Germany | Universitätsklinikum Carl Gustav Carus an der Technischen Universität Dresden | Dresden | |
Germany | Universitätsklinikum Jena | Jena | |
Germany | Universitätsklinikum Leipzig AöR | Leipzig |
Lead Sponsor | Collaborator |
---|---|
University of Jena | Ludwig-Maximilians - University of Munich |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | proportion of patients without AML relapse | impact of midostaurin single treatment on Leukemia-free survival (LFS) | at 12 months after start of midostaurin treatment | |
Secondary | number of patients with low MRD (Minimal Residual Disease) | molecular response to midostaurin treatment | at 3 months after start of midostaurin treatment | |
Secondary | Incidence of acute and chronic graft-versus-host disease (GvHD) | Incidence of acute and chronic GvHD | baseline and every 3 months until 12 months after start of midostaurin treatment | |
Secondary | Incidence of adverse events grade 3-5 of midostaurin after allogeneic SCT | Incidence of adverse events grade 3-5 | baseline and every 3 months until 12 months after start of midostaurin treatment | |
Secondary | Next-generation sequencing analyses of FLT3-mutation | mechanisms of primary or secondary resistance to midostaurin | baseline and every 3 months until 12 months after start of midostaurin treatment | |
Secondary | quality of life assessment with certified "EORTC QLQ - C30 questionnaire" | quality of life assessment with certified "EORTC QLQ - C30 questionnaire" | baseline and every 3 months until 12 months after start of midostaurin treatment |
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