Phase II Study of Lenalidomide Maintenance in Patients with High Risk AML in Remission
The goal of this clinical research study is learn if Revlimid® (lenalidomide) can help to keep AML patients in remission. The safety of this drug will also be studied.
Disease Group: Leukemia
Treatment Agent: Revlimid
Treatment Location: Only at MD Anderson
Primary objective: To assess relapse-free survival (RFS) of patients with acute myeloid leukemia (AML) treated with lenalidomide maintenance therapy after achieving remission. Secondary objective To assess overall survival (OS) of patients with AML treated with lenalidomide maintenance. To assess event-free survival (EFS) of patients with AML treated with lenalidomide maintenance. To assess the duration of remission (CRd) of patients with AML treated with lenalidomide maintenance. To assess toxicity and safety of lenalidomide maintenance in patients with AML. To assess the effects of lenalidomide maintenance on NK cell modulation and dynamics of minimal residual disease and their relationship to outcomes.
IRB Review and Approval Date: 11/13/2014
Recruitment Status: Open
Projected Accrual: N/A
1) Patients aged 18 to 55 years with high risk (as defined in #2) AML
who have achieved their FIRST CR or 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
2) 2. 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, 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 > or = 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.
3) Patients should have received induction chemotherapy for AML and at least 1 consolidation.
4) Patients with history of extramedullary AML, except for CNS involvement that is currently controlled, will not be eligible for enrollment.
5) ECOG performance status of < or = 3
6) Adequate organ function as follows: a. Serum total bilirubin < or = to 1.5 X the Upper Limit of Normal (ULN) b. Serum creatinine < or = to 2.5 x ULN
7) Adequate BM reserve: a. Absolute neutrophil count (ANC) > 0.5 x 109/L b. Platelet count > or = 30 x 109/L
8) 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 24hrs 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.
9) 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.
10) All study participants be willing and able to comply with the requirements of the REMS® program.
11) Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program.
12) Ability to understand and sign informed consent.
1) Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by FAB
classification based on morphology, immunophenotype, molecular, or
cytogenetic s studies.
2) Diagnosis of AML associated with the following karyotypes: inv(16), t(16;16), t(8;21), t(15;17), or t(9;22)
3) 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.
4) Previous treatment with lenalidomide for AML.
5) Patients with documented hypersensitivity to any components of the study program.
6) Females who are pregnant.
7) Patients with active CNS disease
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