A Study of Lenalidomide in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia

Inclusion Criteria

• Participants must satisfy the following criteria to be enrolled in the study:
• Male or female is 1 to ≤ 18 years of age at the time of signing the Informed Consent Form / Informed Assent Form (ICF/IAF).
• Participants (when applicable, parental/legal representative) must understand and voluntarily provide permission to the ICF/IAF prior to conducting any study-related assessments/procedures.
• Participants have relapsed or refractory acute myeloid leukemia after at least 2 prior induction attempts:
• Bone marrow aspirate or biopsy must have ≥ 5% blasts by morphology and/or flow cytometry.
• Each block of chemotherapy is a separate reinduction attempt.
• Donor lymphocyte infusion (DLI) is considered a reinduction attempt.
• Participants are willing and able to adhere to the study visit schedule and other protocol requirements.
• Participants have a Karnofsky score of ≥ 50% (participants ≥ 16 years of age) or a Lansky score ≥ 50% (participants 70 mL/min/1.73 m2.
• Participants have adequate liver function, which is defined as:
• Total bilirubin is ≤ 2 mg/dL unless the increase in bilirubin is attributable to Gilbert's Syndrome
• Aspartate aminotransferase (AST) is ≤ 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for AST is 50 U/L.
• Alanine transaminase (ALT) is ≤ 3.0 x upper normal limit (ULN) for age. For the purpose of this study, the ULN for ALT is 45 U/L.
• Female Children of Childbearing Potential (FCCBP), Female of Childbearing Potential (FCBP) and male participants that have reached puberty must agree to undergo physician-approved reproductive education and discuss the side effects of the study therapy on reproduction with parent(s) and/or guardian(s).
• All participants and/or parents/guardians must have an understanding that lenalidomide could have a potential teratogenic risk. Female children of childbearing potential, is defined as females who have achieved menarche and/or breast development in Tanner Stage 2 or greater and have not undergone a hysterectomy or bilateral oophorectomy and FCBP defined as a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months) must meet the following conditions below (Note: Amenorrhea following cancer therapy does not rule out childbearing potential):
• Medically supervised serum pregnancy tests with a sensitivity of at least 25 mIU/mL must be conducted in FCCBP/FCBP, including those who commit to complete abstinence*. FCCBP/FCBP must have two pregnancy tests (with a minimum sensitivity of 25 mIU/mL) prior to starting treatment with lenalidomide. The first pregnancy test must be performed within 10 - 14 days prior to the start of lenalidomide treatment and the second pregnancy test must be performed within 24 hours prior to starting treatment with lenalidomide.

NOTE: The pregnancy test 10 to 14 days prior to initiation of lenalidomide may be omitted, at the discretion of the investigator, for any FCCBP/FCBP who has high acuity disease requiring immediate treatment with lenalidomide. The pregnancy test within 24 hours prior to the first dose of lenalidomide is required to be performed.

The participants may not received Investigational Product (IP) until the investigator has verified that the results of these pregnancy tests performed on Cycle 1 Day 1 are negative. FCCBP/FCBP with regular or no menstrual cycles must agree to have pregnancy tests weekly for the first 28 days of study participation and then every 28 days while on study, at study Treatment Discontinuation Visit, and at Day 28 following IP discontinuation. If menstrual cycles are irregular, the pregnancy testing must occur weekly for the first 28 days and then every 14 days while on study, at study Treatment Discontinuation Visit, and at Days 14 and 28 following IP discontinuat