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LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia

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ClinicalTrials.gov Identifier: NCT00936611
Recruitment Status : Active, not recruiting
First Posted : July 10, 2009
Last Update Posted : August 28, 2017
Brigham and Women's Hospital
Information provided by (Responsible Party):
Irene Ghobrial, MD, Dana-Farber Cancer Institute

Brief Summary:
The purpose of this research study is to assess the 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.

Condition or disease Intervention/treatment Phase
Waldenstrom's Macroglobulinemia Drug: LBH589 Phase 2

Detailed Description:
  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 37 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Trial of LBH589 (Panobinostat) in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
Study Start Date : June 2009
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: LBH589 Drug: LBH589
Orally on Mondays, Wednesdays and Fridays

Primary Outcome Measures :
  1. To assess the overall response rate in patients with relapsed or relapsed/refractory Waldenstrom's Macroglobulinemia [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. To evaluate the safety of LBH589 in patients with relapsed or relapsed/refractory WM [ Time Frame: 2 years ]
  2. To assess duration of response, time to progression, and progression free survival in these patients [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00936611

United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Principal Investigator: Irene Ghobrial, MD Dana-Farber Cancer Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Irene Ghobrial, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00936611     History of Changes
Other Study ID Numbers: 09-071
CLBH589CUS56T ( Other Identifier: Novartis )
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: August 28, 2017
Last Verified: August 2017

Keywords provided by Irene Ghobrial, MD, Dana-Farber Cancer Institute:

Additional relevant MeSH terms:
Waldenstrom Macroglobulinemia
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action