Lenalidomide in Combination With Microtransplantation as Post-remission Therapy in AML

This is an interventional treatment trial for Acute Myeloid Leukemia (AML) focused on measuring Acute Myeloid Leukemia (AML), Acute Myelocytic Leukemia, Acute Myelogenous Leukemia, Acute Granulocytic Leukemia, Acute Non-Lymphocytic Leukemia Read More

Inclusion Criteria:

• Recipient Inclusion Criteria
• Adults, aged 18 through 75 years of age, with pathologically confirmed acute myelogenous leukemia, in pathologically confirmed complete remission following anti-leukemic therapy.
• AST, ALT and Alkaline Phosphatase <5x Upper Limit normal (ULN), direct bilirubin < 2.0 mg/dl.
• Adequate renal function as defined by: calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault Formula) or serum Cr less than institution ULN (the elderly will often have < 60 GFR)
• ECOG performance status 0-2.
• Have a diagnosis of high-risk AML as established by a poor-risk karyotype, adverse risk by ELN criteria, a therapy-related AML, age ≥ 60 or with antecedent hematologic disorder
• LVEF must be equal to or greater than 40%, as measured by MUGA scan or echocardiogram
• Patients, or appropriate designee, must be able to provide informed consent.
• Must not have received systemic anti-neoplastic therapy, including radiotherapy within 14 days of study treatment.
• Female patients of childbearing age must have negative pregnancy test.
• Male subject agrees to use an acceptable method for contraception during the entire study treatment period and through 6 months after the last dose of lenalidomide.
• All study participants must be registered into the mandatory Revlimid REMS® program, and be willing and able to comply with the requirements of the REMS® program.
• Females of reproductive potential must adhere to the scheduled pregnancy testing as required in the Revlimid REMS® program. If needed, patients should be able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation.
• Donor Inclusion Criteria
• Haploidentical 1st-degree relative as defined by 3/6 or 4/6 HLA-matched at HLA -A, -B, or -DRB1 who is 18-70 years of age
• ECOG performance status 0 or 1
• Excellent health per conventional pre-donor history (medical and psychosocial evaluation)
• No positive testing for viral infection (HbsAg, HIV, HCV)
• Donor ability to understand and provide informed consent
• Meets standard institutional criteria for GCSF mobilized PBSC donation

Exclusion Criteria:

• Recipient Exclusion Criteria
• Diagnosis of acute promyelocytic leukemia
• Active refractory or relapsed acute leukemia
• Prior use of fludarabine, as this agent has been associated with higher subsequent rates of graft versus host disease
• Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 3 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 3 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
• Uncontrolled intercurrent illness that would limit compliance with study requirements.
• HIV-positive individuals on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study drug. In addition, these individuals are at increased risk of lethal infections when treated with marrow-suppressive therapy.
• A diagnosis of active hepatitis B or C as defined by detectable viral load assays in the blood
• Known hypersensitivity to thalidomide or lenalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking lenalidomide.

• Significant cardiac disease as determined by the investigator including:

  • Known or suspected cardiac amyloidosis
  • Congestive heart failure of Class III or IV of the NYHA classification
  • Uncontrolled angina, hypertension or arrhythmia
  • Myocardial infarction in past 6 months
  • Any uncontrolled or severe cardiovascular disease
  • Prior cerebrovascular event with persistent neurologic deficit
• Medical conditions that, in the investigator's opinion, would impose excessive risk to the subject.
• Equal to or greater than grade 2 ataxia, cranial or peripheral neuropathy.
• Systemic infection requiring IV antibiotic therapy within 7 days preceding the first dose of study drug, or other severe infection.
• Pregnant women are excluded from this study.