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Midostaurin in Treating Older Patients With Mutated Acute Myeloid Leukemia Post-Transplant
Not Recruiting
Trial ID: NCT02723435
Purpose
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.
Official Title
An Open-Label Extension Study of Post-Transplant Maintenance Midostaurin (PKC412) in Elderly Patients (Age ≥ 60 Years) With FLT3-ITD/TKD Mutated AML Who Previously Received Midostaurin and Decitabine as Part of Study HEMAML0022 / CPKC412AUS27T
Stanford Investigator(s)
David Iberri
Clinical Assistant Professor, Medicine - Hematology
Eligibility
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:
- Has undergone a hysterectomy or bilateral oophorectomy;
- Has not had menses at any time in the preceding 24 consecutive months
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:
- Uncontrolled diabetes
- Chronic active pancreatitis
- Myocardial infarction within 6 months
- Poorly-controlled hypertension
- Chronic kidney disease
- 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
Intervention(s):
drug: Midostaurin
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Jack Taw
650-723-2781