LBH589 in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma, Hematology |
Therapuetic Areas: | Hematology, Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 11/4/2018 |
Start Date: | June 2009 |
End Date: | December 2021 |
Phase II Trial of LBH589 (Panobinostat) in Relapsed or Relapsed and Refractory Waldenstrom's Macroglobulinemia
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.
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.
- 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.
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
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
We found this trial at
2
sites
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