Mitoxantrone, Etoposide, and Cytarabine (MEC) Plus Lenalidomide for Relapsed or Refractory Acute Myeloid Leukemia
Condition: AML
MeSH terms: Leukemia, Myeloid, Acute
Intervention: Etoposide; Cytarabine; Lenalidomide; Mitoxantrone
Intervention description: A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.; Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.; It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production; It interfere with cell reproduction
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 41.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: AML

Summary:

      This research study is evaluating how a drug called lenalidomide, given in combination with
      the standard chemotherapy regimen of Mitoxantrone, Etoposide, and Cytarabine, commonly
      referred to as MEC, works in individuals with either relapsed or refractory AML
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute myelogenous leukemia diagnosed by WHO criteria with one of the following
             (patients with biphenotypic leukemia are eligible, provided that the treating
             physician determines an AML treatment regimen is appropriate)

               -  Primary refractory disease following > 1cycle of chemotherapy, (such as
                  hypomethylating agent or induction chemotherapy)

               -  First relapse or higher. Patients with primary or secondary acute myelogenous
                  leukemia are eligible.

          -  Age 18-70 years old

          -  LVEF > 50 %

          -  ECOG Performance status 0-2

          -  Able to adhere to study schedule and other protocol requirements.

          -  Participants must have normal organ function as defined below, unless felt due to
             underlying disease and approved by the overall PI. Patients with Gilbert's disease may
             have total bilirubin up to < 3 x ULN.

               -  Creatinine < 2.0mg/dl

               -  Total bilirubin < 1.5 x ULN

               -  AST (SGOT) and ALT (SGPT) < 3 x ULN.

          -  Patients may receive hydroxyurea, steroids, or leukapheresis as necessary until Day 5
             of treatment.

          -  Patients must give voluntary written informed consent and HIPAA authorization before
             performance of any study-related procedure not part of normal medical care, with the
             understanding that consent may be withdrawn by the subject at any time without
             prejudice to future medical care.

          -  Patients may have had prior treatment for MDS or AML, including prior lenalidomide for
             MDS or AML or another condition.

          -  Patient may have had prior autologous or allogeneic transplant (family member,
             unrelated donor, or cord blood) if there is at least 90 days between transplant and
             study entry.

          -  Patients may also have had donor lymphocyte infusion if there is at least 60 days
             between donor lymphocyte infusion and study entry.

          -  Patients on immunosuppression are also eligible.

          -  Females of childbearing potential (FCBP)† must have a negative serum or urine
             pregnancy test with a sensitivity of at least 50 mIU/mL prior to receiving treatment
             with lenalidomide, 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. Men
             must agree to use a latex condom during sexual contact with a FCBP even if they have
             had a successful vasectomy.

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  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

        Exclusion Criteria:

          -  Known hypersensitivity to thalidomide or lenalidomide (if applicable).

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Known seropositive for human immunodeficiency virus (HIV). HIV testing is not
             required. Hepatitis testing is not required.

          -  Patients who have had a myocardial infarction within 6 months of enrollment or has New
             York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina,
             uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute
             ischemia or active conduction system abnormalities.

          -  Any serious medical condition laboratory abnormality or psychiatric illness that would
             prevent the subject from signing the consent form.

          -  Any condition, including laboratory abnormalities, that in the opinion of the
             investigator places the subject at unacceptable risk if he/she were to participate in
             the study or confounds the ability to interpret data from the study.

          -  Patients with major surgery within 28 days prior to treatment.

          -  Patients with any serious medical or psychiatric illness that could, in the
             investigator's opinion, potentially interfere with the completion of treatment
             according to this protocol.

          -  Patient has received an investigational agent or cytotoxic chemotherapy (excluding
             hydroxyurea) within 7 days of study entry.

          -  Patients with acute promyelocytic leukemia.

          -  Females who are pregnant