Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

This study is currently recruiting participants.
Verified June 2012 by Mayo Clinic

First Received on December 14, 2010.  
Last Updated on June 28, 2012  
History of Changes
This Clinical Trial Sponsored By: Mayo Clinic
Collaborator: National Cancer Institute (NCI)
Information provided by: Mayo Clinic
ClinicalTrials.gov Identifier: NCT01261247
 

Purpose for Clinical Trial

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

Condition Study Intervention Clinical Trial Phase
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
Drug: panobinostat
Other: laboratory biomarker analysis
Genetic: western blotting
Genetic: DNA analysis
Other: flow cytometry
Other: pharmacological study
Other: immunohistochemistry staining method
Phase 2

Study Type: Study Interventional
Study Design: Endpoint Classification: Efficacy Study
Study Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma

Resource links provided by NLM:

Genetics Home Reference related topics:
aceruloplasminemia
hemophilia
MedlinePlus related topics:
Cancer
Fungal Infections
Leukemia
Lymphoma

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures For Clinical Trial:

  • Proportion of confirmed responses defined to be a CR or PR noted as the objective status [ Time Frame: Every 28 days for up to 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures For Clinical Trial:

  • Survival time due to any cause; estimated using the method of Kaplan-Meier for the patients included in evaluating the decision criteria [ Time Frame: Every 6 months for up to 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival time due to any cause; will be estimated using the method of Kaplan-Meier [ Time Frame: Every 6 months for up to 2 years ] [ Designated as safety issue: No ]
  • Duration of response as assessed by Kaplan-Meier [ Time Frame: Every 6 months for up to 2 years ] [ Designated as safety issue: No ]
  • Pharmacokinetic/pharmacodynamic of LBH589 and correlation with clinical effects as assessed by immunoblotting, SNPs analysis, serum cytokine assays, and flow cytometry for suppressive monocytes (correlative studies) [ Time Frame: At baseline and day 1 of courses 3, 5, 7 and every three courses thereafter for up to 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 37
Study Start Date: January 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Arm I

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.
Drug: panobinostat

Given orally
Other Names:
  • Faridak
  • HDAC inhibitor LBH589
  • histone deacetylase inhibitor LBH589
  • LBH589

Other: laboratory biomarker analysis

Correlative studies

Genetic: western blotting

Correlative studies
Other Names:
  • Blotting, Western
  • Western Blot

Genetic: DNA analysis

Correlative studies

Other: flow cytometry

Correlative studies

Other: pharmacological study

Correlative studies
Other Name: pharmacological studies

Other: immunohistochemistry staining method

Optional correlative studies
Other Name: immunohistochemistry

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Biopsy-proven relapsed or refractory non-Hodgkin lymphoma requiring treatment, who have failed, unable to tolerate, or refused other available active therapies; patients should not have other treatment options considered curative (NOTE: for patients with lymphoma without CNS involvement, a re-biopsy is necessary unless the patient has had a previous biopsy =< 6 months prior to treatment on this protocol if there has been no intervening treatment; patients with biopsy-proven CNS lymphoma at any time are not required to have a rebiopsy to be eligible for this study); NO

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