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About
This phase 2 trial studies the side effects and how well midostaurin works in treating older patients with acute myeloid leukemia with change in genetic material post-hematopoietic cell transplantation. Midostaruin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving midostaruin post-transplant may improve patient outcomes.
Full description
PRIMARY OBJECTIVES:
I. To determine the efficacy and safety of maintenance midostaurin (a fms related tyrosine kinase 3 [FLT3] inhibitor) for elderly patients with FLT3-internal tandem duplication (ITD)/tyrosine kinase domain (TKD) mutated acute myeloid leukemia (AML) who were previously enrolled on study HEMAML0022/CPKC412AUS27T and have then undergone allogeneic transplant.
SECONDARY OBJECTIVES:
I. To determine whether maintenance midostaurin after allogeneic transplant decreases the relapse rate in patients with FLT3-ITD/TKD mutated AML.
OUTLINE:
Beginning 30 days post-hematopoietic cell transplantation (HCT), patients receive midostaurin orally (PO) twice daily (BID) on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then up to 1 year.
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Inclusion and exclusion criteria
INCLUSION CRITERIA
Elderly patients with FLT3-mutated acute myeloid leukemia (AML)
Prior enrollment in Stanford study IRB-25737
In continued complete remission
≥ 30 days but ≤ 90 days post allogeneic hematopoietic cell transplant (HCT); treatment on this study protocol must begin before day 90 post-HCT
Absolute neutrophil count (ANC) ≥ 1000 cells/uL
Hemoglobin ≥ 8.0 g/dL and not requiring regular transfusions
Platelets ≥ 50,000 cells/uL and not requiring regular transfusions
Aspartate aminotransferase (AST) ≤ 2.5 times upper limit of normal (ULN)
Alanine aminotransferase (ALT) ≤ 2.5 X ULN
Serum bilirubin ≤ 2.5 times ULN
Ability to give written informed consent, including via legally authorized representative
Corrected QT (QTc) ≤ 450 msec
Ejection fraction (EF) ≥ 45% by 2-dimensional transthoracic echocardiography (TTE) or multiple-gated acquisition (MUGA)
Sexually active males, including vasectomized males, must agree via informed consent to use a condom during vaginal, anal, or oral intercourse, while taking midostaurin and for 5 months after stopping midostaurin
Females must have or be:
Negative pregnancy test, within 21 days of the first dose of midostaurin OR
Not of childbearing potential as follows:
EXCLUSION CRITERIA
Uncontrolled acute graft-vs-host disease (GVHD) grade 3 to 4
Uncontrolled active infection
Evidence of active AML (eg, circulating peripheral blasts on complete blood count)
Known confirmed diagnosis of human immunodeficiency virus (HIV) infection
Known confirmed diagnosis of active viral hepatitis
QTc > 450 msec
Congenital long QT syndrome
History of presence of sustained ventricular tachycardia, history of ventricular fibrillation or torsades de pointes
Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm)
Bifascicular block (right bundle branch block plus left anterior hemiblock)
Congestive heart failure (CHF) New York Heart Association (NYHA) class 3 or 4
Cardiac ejection fraction (EF) < 45% within 28 days prior to starting cycle 1
Other known malignancy (except carcinoma in situ)
Other concurrent severe and/or uncontrolled medical condition which could compromise participation in the study, eg:
Received any investigational agent within 30 days prior to day 1
Antineoplastic chemotherapy or radiotherapy within 28 days prior to cycle 1
No plans for concurrent chemotherapy while on study (exception: antineoplastic drugs used as part of GVHD prophylaxis or treatment)
Any surgical procedure, excluding central venous catheter placement, bone marrow biopsy or other minor procedures (eg, skin biopsy) within 14 days of day 1
Unwillingness or inability to comply with the protocol
Known malignant disease of the central nervous system
History of allergic reactions attributed to compounds of similar chemical or biologic composition to midostaurin
Concomitant use of strong inhibitors of cytochrome P450 family 3 subfamily A member 4 (CYP3A4)
Pregnant or lactating
Women of child-bearing potential
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Data sourced from clinicaltrials.gov
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