Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes
Intervention: Lenalidomide 50 mg; Lenalidomide 15 mg
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IPSS Int-2; high risk myelodysplastic syndrome; MDS); 5q31.1 deletions

Summary:

      This is a phase II study of lenalidomide in patients with myelodysplastic syndrome (MDS) and
      with acute myeloid leukemia (AML) with trilineage dysplasia. Patients will receive two cycles
      of lenalidomide. Patients who respond may given additional cycles of lenalidomide until
      disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than 18 years at the time of signing the informed consent form.

          -  Able to adhere to the study visit schedule and other protocol requirements.

          -  MDS or MDS/AML

          -  Patients must not have received any other treatment for their disease, including
             hematopoietic growth factors, within three weeks of beginning the trial

          -  ECOG performance status of 0, 1, or 2 at study entry

          -  All study participants must be registered into the mandatory REMS® program, and be
             willing and able to comply with the requirements of RevAssist®.

          -  Patients must have no clinical evidence of CNS or pulmonary leukostasis, disseminated
             intravascular coagulation, or CNS leukemia.

          -  Subjects must agree to use appropriate contraception.

        Exclusion Criteria:

          -  Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing the informed consent form.

          -  Pregnant or breast feeding females. (Lactating females must agree not to breast feed
             while taking lenalidomide).

          -  Any condition, including the presence of laboratory abnormalities, which 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.

          -  Use of any other experimental drug or therapy within 21 days of baseline.

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Any prior use of lenalidomide except for MDS patients with del 5q31.1 abnormalities..

          -  Concurrent use of other anti-cancer agents or treatments.

          -  Patients may not have received prior AML induction chemotherapy or stem cell
             transplant. However, patients with secondary MDS who have received a stem cell
             transplant for other indications (eg lymphoma, multiple myeloma) will be eligible.