Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction

Patients ≥60 years of age with AML

* Patients with therapy-related myeloid neoplasms are allowed

* Patients with AML that has evolved from an antecedent hematologic disorder are allowed

* Patients will be eligible regardless of their ultimate plans or candidacy for allogeneic stem cell transplant

All study participants must be registered into the mandatory RevAssist® program, and be willing and able to comply with the requirements of RevAssist®.

Females of childbearing potential (FCBP; see definition below) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10 - 14 days and again within 24 hours prior to prescribing lenalidomide for re-induction/consolidation (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing.

* A FCBP is a sexually mature female who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy. See Appendix C: Risks of Fetal Exposure, Pregnancy Testing Guidelines and Acceptable Birth Control Methods.

Patients must have been treated with 1-2 courses of intensive therapy as first therapy for AML, commonly described as induction. These therapies should include cytarabine at a dose ≥700 mg/m2 in combination with an anthracycline or anthracenedione (≥ 135 mg/m2 of daunorubicin, 36 mg/m2 of idarubicin or 40 mg/m2 of mitoxantrone)

Patients must be in morphologic complete response (CR), complete response with incomplete hematologic recovery (CRi) or partial response (PR) by international working group criteria post induction therapy (see Appendix A). Patients in PR who have undergone only one course of intensive induction therapy will be eligible only if one or more of the following criteria are met:

* Patient preference to forgo further intensive induction therapy in favor of low- or intermediate-intensity therapy

* Patients are deemed unlikely to benefit from additional anthracycline-cytarabine induction therapies for any of the following reasons:

* Therapy-related AML

* Prior myelodysplastic syndrome or myeloproliferative neoplasm

* The presence of cytogenetic or molecular genetic features place patient in the Intermediate-I, Intermediate -II or Adverse genetic group as defined by the European LeukemiaNet

* Patients who have experienced one or more CTCAE v4.0 grade 3-4 treatment-related non-hematologic toxicity within 30 days of beginning the first course of induction therapy.

Patients must have recovered from all infectious and non-hematologic toxicities from prior chemotherapy to ≤ CTCAE grade 1 or baseline prior to study enrollment.

Adequate renal and hepatic functions as indicated by the following:

* Renal function assessed by calculated creatinine clearance (CrCl) must be \>/= 60ml/min by Cockcroft-Gault formula (

* Serum total bilirubin ≤ 1.5 x upper limit of normal (ULN)

* AST/ALT ≤ 2.5 x ULN

Patients in CRi must have evidence of hematologic recovery after prior therapy to at least:

* Absolute neutrophils ≥ 0.8 x 109/L

* Platelets ≥ 75 x 109/L

* Independent of red blood cell transfusions

ECOG performance status 0-2

Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction

What this study is about

Lenalidomide as Consolidation and Maintenance in Adults >/= 60 Years of Age With AML Following Standard Induction

What this study is about