LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
Condition: Waldenstrom's Macroglobulinemia
MeSH terms: Waldenstrom Macroglobulinemia
Intervention: LBH589
Intervention MeSH terms: Panobinostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: LBH589; WM; panobinostat; relapsed; waldenstrom; macroglobulinemia

Summary:

      The purpose of this research study is to assess the overall response rate of LBH589 in
      patients with relapsed or refractory Waldenstrom's Macroglobulinemia. LBH589 is a newly
      discovered compound that has killed Waldenstrom cells in laboratory studies, however, it is
      not known if LBH589 will show the same activity in people with Waldenstrom's
      Macroglobulinemia. This drug has been used in research for the treatment of other types of
      cancer, such as multiple myeloma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged 18 years or older

          -  Must have received prior therapy for their WM, any number of prior therapies is
             allowed

          -  Must have symptomatic relapsed or refractory WM

          -  Measurable monoclonal IgM protein in the blood and presence of lymphoplasmacytic cells
             in the bone marrow during any previous bone marrow

          -  Laboratory values as described in the protocol

          -  Clinically euthyroid

          -  ECOG Performance Status of 2 or less

        Exclusion Criteria:

          -  Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer

          -  Patients who will need valproic acid for any medical condition during the study or
             within 5 days prior to first LBH589 treatment

          -  Peripheral neuropathy CTCAE grade 2 or higher

          -  Impaired cardiac function or clinically significant cardiac diseases

          -  Impairment of GI function or GI disease that may significantly alter the absorption of
             LBH589

          -  Diarrhea > CTCAE grade 1

          -  Other concurrent severe and/or uncontrolled medical conditions including abnormal
             laboratory values, that could cause unacceptable safety risks or compromise compliance
             with the protocol

          -  Patients using medications that have a relative risk of prolonging the QT interval or
             inducing torsade de pointes if treatment cannot be discontinued or switched to a
             different medication prior to starting study drug

          -  Patients who have received targeted agents within 2 weeks or within 5 half-lives of
             the agent and active metabolites (whichever is longer) and who have not recovered from
             side effects of those therapies

          -  Patients who have received chemotherapy or rituximab within 3 weeks or less; or
             radiation therapy to > 30% of marrow-bearing bone within 2 weeks or less prior to
             starting study treatment; or who have not yet recovered from side effects of such
             therapies

          -  Patients who have received corticosteroids 2 weeks or less prior to registration.
             Patients may be receiving chronic corticosteroids if they are being given for
             disorders other than than Waldenstrom's Macroglobulinemia

          -  Patients with active bleeding tendency or receiving any treatment with therapeutic
             doses of sodium warfarin or coumadin derivatives. Low doses of Coumadin to maintain
             line patency is allowed

          -  Patients who have undergone major surgery 4 weeks or less prior to starting study drug
             or who have not recovered from side effects of such therapy

          -  Women who are pregnant or breast feeding or women of childbearing potential not using
             an effective method of birth control

          -  Male patients whose sexual partners are women of childbearing potential not using
             effective methods of birth control

          -  Patients with prior malignancy within the last 5 years (except for basal or squamous
             cell carcinoma, or in situ cancer of the cervix)

          -  Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis C;
             baseline testing for HIV and hepatitis C is not required

          -  Patients with a significant history of non-compliance to medical regimens or unwilling
             or unable to comply with the instructions given to him/her by the study staff