Lenalidomide and Azacitidine in Treating Patients With Advanced Myelodysplastic Syndromes
Condition: Leukemia; Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Lenalidomide may stop the growth of cancer cells by blocking blood flow to the
      cancer. Lenalidomide may also stimulate the immune system in different ways and stop cancer
      cells from growing. Drugs used in chemotherapy, such as azacitidine, work in different ways
      to stop the growth of cancer cells, either by killing the cells or by stopping them from
      dividing. Azacitidine may also cause cancer cells to look more like normal cells, and to grow
      and spread more slowly. Giving lenalidomide together with azacitidine may kill more cancer
      cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of lenalidomide and
      azacitidine in treating patients with advanced myelodysplastic syndromes.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the maximum tolerated dose and dose-limiting toxicity of lenalidomide and
           azacitidine in patients with advanced myelodysplastic syndromes (MDS).

      Secondary

        -  Review clinical outcomes, as defined by the International Working Group criteria, in
           patients treated with this regimen.

        -  Determine time to transformation to acute myeloid leukemia or death in patients treated
           with this regimen.

        -  Determine time to relapse after achieving complete or partial remission in patients
           treated with this regimen.

        -  Determine time to disease progression in patients treated with this regimen.

        -  Determine the effect of this regimen on hematologic status (including peripheral blood
           counts and the need for platelet and/or red blood cell transfusions) in these patients.

      OUTLINE: This is an open-label, multicenter, dose-escalation study.

      Patients receive oral lenalidomide once daily on days 1-14 or days 1-21 and azacitidine
      subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days
      for up to 7 courses in the absence of relapse (after achieving complete or partial
      remission), disease progression, or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses and/or increasing dosing frequencies of
      lenalidomide and azacitidine until the maximum tolerated dose (MTD) is determined or the
      sixth dose level is reached, whichever occurs first. The MTD is defined as the dose preceding
      that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first
      course of therapy.

      After completion of study treatment, patients are followed annually.
    

Intervention name(s): azacitidine; lenalidomide
Intervention type(s): Drug; Drug
Intervention description(s): Azacitidine subcutaneously once daily on days 1-5 or days 1-5 and 8-12. Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.; Oral lenalidomide once daily on days 1-14 or days 1-21.Treatment repeats every 28 days for up to 7 courses in the absence of relapse (after achieving complete or partial remission), disease progression, or unacceptable toxicity.
Other intervention name(s): Vidaza®; Revlimid®
Intervention MeSH terms: Lenalidomide; Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: refractory anemia with excess blasts; previously treated myelodysplastic syndromes; chronic myelomonocytic leukemia; de novo myelodysplastic syndromes; secondary myelodysplastic syndromes