Lenalidomide and Prednisone in Treating Patients With Myelofibrosis
Condition: Essential Thrombocythemia; Polycythemia Vera; Primary Myelofibrosis
MeSH terms: Polycythemia Vera; Primary Myelofibrosis; Polycythemia; Thrombocytosis; Thrombocythemia, Essential
Intervention: lenalidomide; prednisone; laboratory biomarker analysis
Intervention description: Given orally (PO); Given PO; Correlative studies
Intervention MeSH terms: Prednisone; Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well giving lenalidomide together with prednisone works
      in treating patients with myelofibrosis. Lenalidomide may stop the growth of myelofibrosis by
      blocking blood flow to the cancer. It may also stimulate the immune system in different ways
      and stop cancer cells from growing. Drugs used in chemotherapy, such as prednisone, 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 prednisone may kill more cancer cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient must be diagnosed with myelofibrosis with myeloid metaplasia (MMM); agnogenic
             myeloid metaplasia, post-polycythemic myeloid metaplasia, or post-thrombocythemic
             myeloid metaplasia are included

               -  NOTE: Diagnosis must be confirmed by central pathology review; diagnostic samples
                  must be submitted; patient may register and begin treatment based on the local
                  pathology review. If the central review does not confirm patient's eligibility to
                  participate in the trial, protocol treatment must be discontinued

          -  Patient must have discontinued chemotherapy (hydroxyurea, alpha interferon,
             anagrelide, other myelosuppressive agents, thalidomide, or any other experimental
             therapy) as well as growth factors and systemic use of corticosteroids >= 28 days
             prior to starting study drug

               -  All non-hematologic toxicity must be resolved to =< grade 1

          -  Patient must be lenalidomide-naïve (never treated with lenalidomide)

          -  ECOG performance status (PS) of 0, 1, or 2 at study entry

          -  Hemoglobin level =< 10 g/dL or transfusion-dependent

          -  Absolute neutrophil count >= 1,000 uL

          -  Platelet count >= 100,000 uL

          -  Serum creatinine =< 2.0 mg/dL

          -  Total bilirubin =< 2.0 mg/dL (if elevated; direct bilirubin =< 2.0 mg/dL)

          -  AST (SGOT) =< 3 x ULN unless attributed to hepatic extramedullary hematopoiesis

          -  Women must not be pregnant or breastfeeding because this study involves an
             investigational agent whose genotoxic, mutagenic, and teratogenetic effects on the
             developing fetus and newborn are unknown; women of childbearing potential who are
             sexually active, must use 2 accepted methods of birth control at the same time for 4
             weeks prior to lenalidomide treatment, during lenalidomide treatment, and up to 4
             weeks after lenalidomide treatment is finished; sexually active males must use a latex
             condom for contraception during the study and up to 4 weeks after treatment with
             lenalidomide has ended

               -  All females of childbearing potential must have a blood test 10-14 days prior to
                  the start of lenalidomide treatment to rule out pregnancy; another blood test to
                  rule out pregnancy must be done 24 hours prior to the start of treatment with
                  lenalidomide

          -  Patient must not have any condition, including the presence of laboratory
             abnormalities, which, based on the physician's opinion, places the patient at
             unacceptable risk if he/she were to participate in the study or confounds the ability
             to interpret data from the study

          -  Patient must not have any known hypersensitivity to thalidomide or lenalidomide

          -  Patient must not have any known positive status for HIV or infectious hepatitis type
             A, B or C

          -  Patient must not have any other active malignancy

               -  NOTE: SWOG patients are strongly encouraged to be registered on SWOG-9007
                  ("Cytogenetic Studies in Leukemia Patients"); SWOG institutions registering
                  patients to SWOG-9007 should follow the instructions for specimen submission