Lenalidomide Plus Chemotherapy for AML
Condition: Acute Myelogenous Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is a Phase I clinical trial. Phase I clinical trials test the safety of
      an investigational combination of drugs. Phase I studies also try to define the appropriate
      dose of the investigational combination of drugs to use for further studies.
      "Investigational" means that the combination of drugs is still being studied and that
      research doctors are trying to find out more about it. It also means that the FDA has not
      approved this combination of drugs for AML. As part of this research study, you will take
      lenalidomide in combination with MEC. MEC are FDA approved chemotherapy drugs that are
      commonly used in the treatment of AML. Lenalidomide is approved by the FDA for patients with
      multiple myeloma, and some patients with myelodysplasia. Lenalidomide is considered
      investigational in this research study because it is not approved by the FDA for patients
      with AML.

      Lenalidomide is a drug that affects the immune system, called an immunomodulatory drug or
      IMID. This drug is successful in the treatment of patients with multiple myeloma and some
      patients with myelodysplasia, a pre-leukemic condition. Other research studies suggest that
      lenalidomide may also be effective in patients with AML. Since we know that many patients who
      receive MEC chemotherapy alone do not have a prolonged remission (time free from leukemia),
      we are studying the addition of lenalidomide to MEC.

      In this research study, we are looking for the highest dose of lenalidomide that can be given
      safely with MEC.
    

Detailed description: 
      After undergoing screening procedures to confirm that you are eligible to participate in the
      research study you will be admitted to the hospital. You will likely receive the majority of
      treatment on an inpatient basis. You will remain in the hospital for at least Days 4-8 and
      will be discharged at the discretion of your study doctor. It is likely that you will be
      hospitalized for several weeks due to the risk of infection after chemotherapy.

      Since we are looking for the highest dose of the study drug that can be administered safely
      without severe or unmanageable side effects in participants that have relapsed or refractory
      AML, not everyone who participates in this research study will receive the same dose of the
      study drug. The dose you get will depend on the number of participants who have been enrolled
      in the study before you and how well they have tolerated their doses.

      If you take part in this study you will be given a study drug-dosing calendar. There is only
      one cycle of treatment, which will be 28 days long. On Days 1 to 14 you will receive the
      lenalidomide orally. On Days 4-8 you will receive MEC chemotherapy: mitoxantrone by IV
      (intravenously, into your vein) over 30 minutes, etoposide by IV over one hour, and
      cytarabine by IV over one hour.

      While on this study you will undergo a daily clinical exam for the first 14 days and then at
      least twice a week until your blood counts recover from treatment. A clinical exam consists
      of a physical exam, questions about your general health and specific questions about any
      problems that you might be having and any medications you may be taking. You will also
      undergo blood tests to assess your disease status and determine organ function level. This
      will happen daily for the first 14 days and then at least once a week (but up to 3 times per
      week) until your blood counts recover from treatment. Additionally a bone marrow
      aspirate/biopsy will be completed at the time of blood cell count recovery (usually between
      days 20 and 45) and as clinically indicated.

      We would like to keep track of your medical condition for up to two years after your final
      dose of study drug. We would like to do this by getting in touch with you every 6 months to
      see how you are doing. Keeping in touch with you and checking your condition helps us look at
      the long-term effects fo the research study.
    

Intervention name(s): Lenalidomide; Mitoxantrone; Etoposide; Cytarabine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Etoposide; Mitoxantrone; Lenalidomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Relapsed; Refractory