PRIMARY OBJECTIVE:
I. To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML)
treated with lenalidomide maintenance therapy after achieving remission.
SECONDARY OBJECTIVES:
I. To assess overall survival (OS) of patients with AML treated with lenalidomide
maintenance.
II. To assess event-free survival (EFS) of patients with AML treated with lenalidomide
maintenance.
III. To assess the duration of remission (CRd) of patients with AML treated with lenalidomide
maintenance.
IV. To assess toxicity and safety of lenalidomide maintenance in patients with AML.
V. To assess the effects of lenalidomide maintenance on natural killer (NK) cell modulation
and dynamics of minimal residual disease and their relationship to outcomes.
OUTLINE:
Patients receive lenalidomide orally (PO) once daily (QD) on days 1-28. Treatment repeats
every 28 days for up to 24 cycles in the absence of disease progression or unacceptable
toxicity.
After completion of study treatment, patients are followed up every 6-12 months.
Inclusion Criteria:
- Patients aged 18 to 55 years with high risk AML who have achieved their FIRST complete
remission (CR) or complete remission with incomplete recovery (CRi) within 12 months
of enrollment and are not immediately candidates for allogeneic stem cell transplant;
patients above age 55 who are not eligible for other protocols may be considered for
enrollment on a case by case basis after discussion with the principal investigator
(PI)
- Patients in their FIRST CR or CRi may be eligible for enrollment only if they have a
high risk feature, including, but not limited to: adverse karyotype, fms-related
tyrosine kinase 3 (FLT3) mutation, history of antecedent hematologic disorder (AHD),
presence of dysplasia in the bone marrow, therapy-related AML, history of requiring
more than 1 cycle of intensive induction chemotherapy to achieve first remission, or
presence of persistent minimal residual disease (detected by cytogenetics, molecular
markers, or flow cytometry) at any point after initial induction cycle; patients aged
>= 18 years with AML who have achieved a SECOND CR or CRi within 12 months of
enrollment and are not immediately candidates for allogeneic stem cell transplant are
also eligible
- Patients should have received induction chemotherapy for AML and at least 1
consolidation
- Patients with history of extramedullary AML, except for central nervous system (CNS)
involvement that is currently controlled, will not be eligible for enrollment
- Eastern Cooperative Oncology Group (ECOG) performance status of < or = 3
- Serum total bilirubin < or = to 1.5 X the upper limit of normal (ULN)
- Serum creatinine < or = to 2.5 x ULN
- Absolute neutrophil count (ANC) > 0.5 x 10^9/L
- Platelet count > or = 30 x 10^9/L
- For females of childbearing age, they may participate it they: a. have a negative
serum or urine pregnancy test within 10 to 14 days of enrolling (a second pregnancy
test will be performed within 24 hours (hrs) of starting therapy and both negative
pregnancy tests will be required for starting therapy); b. agree to either abstinence
or 2 effective contraceptive methods throughout the treatment period and up to 28 days
after discontinuing treatment
- For male patients with a female partner of childbearing age, they may participate if
they agree to either abstinence or 2 effective contraceptive methods throughout the
treatment period and up to 28 days after discontinuing treatment
- All study participants be willing and able to comply with the requirements of the Risk
Evaluation and Mitigation Strategies (REMS) program
- Females of reproductive potential must adhere to the scheduled pregnancy testing as
required in the Revlimid REMS program
- Ability to understand and sign informed consent
Exclusion Criteria:
- Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French American British
(FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics
studies
- Diagnosis of AML associated with the following karyotypes: inversion (inv)(16),
t(16;16), t(8;21), t(15;17), or t(9;22)
- Uncontrolled intercurrent illness including, but not limited to ongoing or active
uncontrolled infection, symptomatic congestive heart failure, unstable angina
pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
limit compliance with study requirements
- Previous treatment with lenalidomide for AML
- Patients with documented hypersensitivity to any components of the study program
- Females who are pregnant
- Patients with active CNS disease
