This pilot phase II trial studies how well selinexor works when given together with induction, consolidation, and maintenance therapy in treating older patients with acute myeloid leukemia. Selinexor may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cytarabine and daunorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Selinexor with induction, consolidation, and maintenance therapy may kill more cancer cells in older patients with acute myeloid leukemia.
PRIMARY OBJECTIVES: I. To compare the overall survival of patients receiving the proposed study regimen versus standard of care (defined as time from randomization to death from any cause). SECONDARY OBJECTIVES: I. To compare the response rate (Complete remission (CR), complete remission with incomplete count recovery (CRi) as per Dhoner et. al.) of patients receiving the proposed study regimen versus standard of care (SOC). II To compare disease free survival in patients receiving the proposed study regimen vs standard of care (defined as time from randomization to relapse or death from any cause). III. To assess the rate of allogeneic stem cell transplantation IV. To compare the toxicity of the proposed study regimen vs standard of care. OUTLINE: INDUCTION THERAPY: Patients receive cytarabine intravenously (IV) on days 1-7, daunorubicin hydrochloride IV on days 1-3, and selinexor orally (PO) twice weekly from day 1. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. RE-INDUCTION THERAPY: Patients whose disease has not responded receive cytarabine IV on days 1-5, daunorubicin hydrochloride IV on days 1-2, and selinexor PO twice weekly. Treatment continues for 14 days in the absence of disease progression or unacceptable toxicity. CONSOLIDATION THERAPY: Patients in remission receive cytarabine IV every 12 hours on days 1-3, and selinexor PO twice weekly from day 1. Treatment repeats every 42 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 14 days and then every 3 months for up to 1 year.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
57
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, United States
Overall survival
Kaplan-Meier estimation will be used to analyze the overall survival. Overall survival (OS) is measured from the date of randomization to the date of death due to any cause. Participants will be monitored for survival through routine follow-up visits.
Time frame: Up to 1 year
Response rate of complete remission (CR) or complete remission with incomplete recovery (CRi)
Confidence intervals will be calculated around the estimates of the response rate (complete remission and complete remission with incomplete recovery). Complete remission (CR): Defined by the absence of leukemia cells in the blood and bone marrow. Partial remission with incomplete hematologic recovery (CRi): This is a more stringent criterion, requiring a normal platelet count along with a normal ANC.
Time frame: Up to 1 year
Progression-free survival
Kaplan-Meier survival analysis methods to compare time to progression.
Time frame: Up to 1 year
Rate of allogeneic stem cell transplantation
Fisher's exact tests to compare rates.
Time frame: Up to 1 year
Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events version 4.0
The frequency of toxicities experienced by the participants will be presented by type and grade in an effort to monitor and report safety of the treatment.
Time frame: Up to 1 year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.