Trial Search Results

Study of Oral LBH589 in Adult Patients With Refractory/Resistant Cutaneous T-Cell Lymphoma

This study will evaluate the safety and efficacy of LBH589B in adult patients with refractory/resistant Cutaneous T-Cell Lymphoma and prior HDAC inhibitor therapy.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Intervention(s):

  • Drug: LBH589

Phase:

Phase 2/Phase 3

Eligibility


Inclusion criteria:

   1. Written informed consent obtained prior to any screening procedures

   2. Age greater than or equal to 18 years old

   3. Patients with biopsy-confirmed stages IB-IVA mycosis fungoides or Sézary syndrome.
   Patients with SS who have bone marrow involvement are also eligible. Patients with
   transformed CTCL are eligible.

   4. Patients must have been treated with an HDAC inhibitor given for the treatment of
   CTCL. Patients must have had disease progression on or following treatment with an
   HDAC inhibitor. Patients are also eligible if they had an inadequate response to an
   HDAC inhibitor defined as stable disease as the best response after at least 3 months
   of therapy. Patients previously treated with an HDAC inhibitor are also eligible if
   they experienced intolerance due to adverse events.

Exclusion criteria:

   1. Patients with a history of visceral disease including CNS involvement (i.e. stage IVB
   CTCL). Note, patients who have SS with bone marrow involvement are eligible.

   2. Impaired cardiac function

   3. Concomitant use of drugs with a risk of causing torsades de pointes

   4. Patients who have received chemotherapy or any investigational drug or undergone major
   surgery ≤ 3 weeks prior to starting study drug or who have not recovered from side
   effects of such therapy

   5. Less than 3 months since prior electron beam therapy

   6. Women who are pregnant or breast feeding, or women of childbearing potential (WOCBP)
   not willing to use a double method of contraception during the study and 3 months
   after the end of treatment.

Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Natalie Viakhireva
6507238949
Not Recruiting