Phase I Study of Lenalidomide and Conventional Chemotherapy in Acute Myeloid Leukemia
I. To determine the maximum tolerated dose (MTD) of lenalidomide in combination with
conventional chemotherapy in two separate cohorts of patients with 1) relapsed or refractory
acute myeloid leukemia (AML) and 2) age >= 60 with untreated AML and recommend starting
doses for phase II studies of this combination of agents.
I. To define the qualitative and quantitative toxicities of these combinations of agents in
regard to organ specificity, time course, predictability, and reversibility.
II. To document the therapeutic response of these combinations of agents in patients with
poor risk AML.
III. To conduct pharmacodynamic studies to investigate the potential mechanism of
lenalidomide activity in this trial.
OUTLINE: This is a dose-escalation study of lenalidomide.
COHORT I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, cytarabine
IV continuously over 96 hours on days 5-8, and idarubicin IV over 1 hour on days 5-7.
COHORT II: Patients receive lenalidomide PO QD on days 1-21, cytarabine IV continuously over
24 hours on days 5-11, and idarubicin as above.
Patients with residual disease on day 18 undergo a second course of induction therapy.
COHORT I: Patients receive lenalidomide PO QD on days 1-14, idarubicin IV over 1 hour on
days 5-6, cytarabine IV continuously on days 5-7. Treatment continues for 1 course in the
absence of disease progression or unacceptable toxicity.
COHORT II: Patients 2 receive 4 courses of consolidation therapy comprising lenalidomide PO
QD on days 1-14 and cytarabine IV every 12 hours on days 5, 7, and 9. Treatment repeats
every 28 days for up to 4 courses in the absence of disease progression or unacceptable
After completion of study treatment, patients are followed up for 30 days.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
MTD of lenalidomide, determined according to incidence of dose-limiting toxicity (DLT) graded using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Ohio State University
United States: Food and Drug Administration
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Ohio State University Medical Center||Columbus, Ohio 43210|