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Phase II Trial of LBH589 (Panobinostat) in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia

Phase 2
18 Years
Open (Enrolling)
Waldenstrom's Macroglobulinemia

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Trial Information

Phase II Trial of LBH589 (Panobinostat) in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia

- Each cycle lasts 4 weeks (28 days). Participants will take LBH589 orally once a day on
Monday, Wednesday and Friday of each week.

- While participants are receiving LBH589, and before the start of each study cycle, they
will come to the clinic for the following tests and procedures: physical examination,
blood work and EKG.

- Participants may continue to receive LBH589 for as long as the study doctor determines
that they are benefiting.

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To assess the overall response rate in patients with relapsed or relapsed/refractory Waldenstrom's Macroglobulinemia

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Irene Ghobrial, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Food and Drug Administration

Study ID:




Start Date:

June 2009

Completion Date:

September 2013

Related Keywords:

  • Waldenstrom's Macroglobulinemia
  • LBH589
  • WM
  • panobinostat
  • relapsed
  • waldenstrom
  • macroglobulinemia
  • Waldenstrom Macroglobulinemia



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Rocky Mountain Cancer CentersThornton, Colorado  80260