Lenalidomide, Cytarabine, and Idarubicin in Treating Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22;q23); MLLT3-MLL; Adult Acute Promyelocytic Leukemia With t(15;17)(q22;q12); PML-RARA; Alkylating Agent-Related Acute Myeloid Leukemia; de Novo Myelodysplastic Syndrome; Previously Treated Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Secondary Myelodysplastic Syndrome; Untreated Adult Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Neoplasm Metastasis; Leukemia, Promyelocytic, Acute; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial studies the side effects and best dose of lenalidomide when given together
      with cytarabine and idarubicin in treating patients with acute myeloid leukemia. Biological
      therapies, such as lenalidomide, may stimulate the immune system in different ways and stop
      cancer cells from growing. Drugs used in chemotherapy, such as cytarabine and idarubicin,
      work in different ways to stop the growth of cancer cells, either by killing the cells or by
      stopping them from dividing. Giving lenalidomide together with cytarabine and idarubicin may
      kill more cancer cells.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To determine the maximum tolerated dose (MTD) of lenalidomide in combination with
      conventional chemotherapy in two separate cohorts of patients with 1) relapsed or refractory
      acute myeloid leukemia (AML) and 2) age >= 60 with untreated AML and recommend starting doses
      for phase II studies of this combination of agents.

      SECONDARY OBJECTIVES:

      I. To define the qualitative and quantitative toxicities of these combinations of agents in
      regard to organ specificity, time course, predictability, and reversibility.

      II. To document the therapeutic response of these combinations of agents in patients with
      poor risk AML.

      III. To conduct pharmacodynamic studies to investigate the potential mechanism of
      lenalidomide activity in this trial.

      OUTLINE: This is a dose-escalation study of lenalidomide.

      INDUCTION:

      COHORT I: Patients receive lenalidomide orally (PO) once daily (QD) on days 1-21, cytarabine
      intravenously (IV) continuously over 96 hours on days 5-8, and idarubicin IV over 1 hour on
      days 5-7.

      COHORT II: Patients receive lenalidomide PO QD on days 1-21, cytarabine IV continuously over
      24 hours on days 5-11, and idarubicin as above.

      Patients with residual disease on day 18 undergo a second course of induction therapy.

      CONSOLIDATION:

      COHORT I: Patients receive lenalidomide PO QD on days 1-14, idarubicin IV over 1 hour on days
      5-6, cytarabine IV continuously on days 5-7. Treatment continues for 1 course in the absence
      of disease progression or unacceptable toxicity.

      COHORT II: Patients 2 receive 4 courses of consolidation therapy comprising lenalidomide PO
      QD on days 1-14 and cytarabine IV every 12 hours on days 5, 7, and 9. Treatment repeats every
      28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed up for 30 days.
    

Intervention name(s): Lenalidomide; Cytarabine; Idarubicin; Pharmacological Study; Laboratory Biomarker Analysis
Intervention type(s): Drug; Drug; Drug; Other; Other
Intervention description(s): Given PO; Given IV; Given IV; Correlative studies; Correlative studies
Other intervention name(s): CC-5013; CC5013; CDC 501; IMiD-1; CHX-3311; U-19920; Idamycin; IMI-30; SC-33428; Zavedos; pharmacological studies
Intervention MeSH terms: Cytarabine; Lenalidomide; Idarubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment