Acute Myeloid Leukemia Clinical Trial
Official title:
Phase I Study of Decitabine (Dacogen) and Selinexor (KPT-330) in Acute Myeloid Leukemia
This phase I trial studies the side effects and best dose of Selinexor when given together with decitabine in treating patients with acute myeloid leukemia that has returned after treatment (relapsed) or does not respond to treatment (refractory). Drugs used in chemotherapy, such as decitabine and Selinexor, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.
PRIMARY OBJECTIVES:
I. To evaluate the safety and tolerability of Selinexor (KPT‐330) in combination with
decitabine in patients with acute myeloid leukemia (AML).
II. To define the specific toxicities, maximum tolerated dose (MTD) and the dose limiting
toxicity (DLT) of this combination.
III. To determine the Recommended Phase 2 Dose (RP2D) of this combination.
SECONDARY OBJECTIVES:
I. To determine the overall response rate (ORR). II. To determine the rate and duration of
complete remission (CR) +/- hematological recovery of KPT‐330 plus decitabine in AML.
III. To conduct pharmacodynamic studies by measuring the effect of this chemotherapy
combination on the kinome, micronome and epigenome.
OUTLINE: This is a dose-escalation study of selinexor.
INDUCTION: Patients receive decitabine intravenously (IV) over 1 hour on days 1-10 and
Selinexor orally (PO) on days 11, 13, 18, 20, 25 and 27. Treatment repeats every 31 days for
up to 4 courses in the absence of disease progression or unacceptable toxicity.
MAINTENANCE: Patients receive decitabine IV over 1 hour on days 1-5 and Selinexor PO on days
6, 8, 13, 15, 20 and 22. Courses repeat every 31 days in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
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