Trials / Completed
CompletedNCT01261247
Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 41 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well panobinostat works in treating patients with relapsed or refractory non-Hodgkin lymphoma
Detailed description
PRIMARY OBJECTIVES: I. To evaluate the proportion of confirmed response of LBH589 in patients with relapsed or refractory non-Hodgkin lymphoma. SECONDARY OBJECTIVES: I. To describe the toxicities associated with LBH589 in patients with NHL. II. To evaluate overall survival, progression-free survival, and duration of response in patients treated with LBH589. TERTIARY OBJECTIVES: I. To evaluate the pharmacokinetics of LBH589. II. To assess the correlation between clinical (toxicity and/or tumor response or activity) effects with the pharmacologic (pharmacokinetic/pharmacodynamic) parameters, and/or biologic (correlative laboratory) results. OUTLINE: Patients receive oral panobinostat 3 times weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for up to 2 years.
Conditions
- Adult Nasal Type Extranodal NK/T-cell Lymphoma
- Anaplastic Large Cell Lymphoma
- Angioimmunoblastic T-cell Lymphoma
- Extranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid Tissue
- Hepatosplenic T-cell Lymphoma
- Nodal Marginal Zone B-cell Lymphoma
- Peripheral T-cell Lymphoma
- Post-transplant Lymphoproliferative Disorder
- Recurrent Adult Burkitt Lymphoma
- Recurrent Adult Diffuse Large Cell Lymphoma
- Recurrent Adult Lymphoblastic Lymphoma
- Recurrent Adult T-cell Leukemia/Lymphoma
- Recurrent Grade 1 Follicular Lymphoma
- Recurrent Grade 2 Follicular Lymphoma
- Recurrent Grade 3 Follicular Lymphoma
- Recurrent Mantle Cell Lymphoma
- Recurrent Mycosis Fungoides/Sezary Syndrome
- Recurrent Small Lymphocytic Lymphoma
- Small Intestine Lymphoma
- Splenic Marginal Zone Lymphoma
- Waldenstrom Macroglobulinemia
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | panobinostat | Given orally |
| OTHER | laboratory biomarker analysis | Correlative studies |
| GENETIC | western blotting | Correlative studies |
| GENETIC | DNA analysis | Correlative studies |
| OTHER | flow cytometry | Correlative studies |
| OTHER | pharmacological study | Correlative studies |
| OTHER | immunohistochemistry staining method | Optional correlative studies |
Timeline
- Start date
- 2011-01-17
- Primary completion
- 2016-05-09
- Completion
- 2019-12-02
- First posted
- 2010-12-16
- Last updated
- 2022-05-24
- Results posted
- 2018-05-17
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01261247. Inclusion in this directory is not an endorsement.