Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma
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|ClinicalTrials.gov Identifier: NCT01261247|
Recruitment Status : Active, not recruiting
First Posted : December 16, 2010
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
|Condition or disease||Intervention/treatment||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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of the Histone Deacetylase (HDAC) Inhibitor LBH589 (Panobinostat) in Patients With Relapsed or Refractory Non-Hodgkin Lymphoma|
|Study Start Date :||January 2011|
|Actual Primary Completion Date :||May 9, 2016|
|Estimated Study Completion Date :||November 2018|
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.
Other Names:Other: laboratory biomarker analysis
Correlative studiesGenetic: western blotting
Other Names:Genetic: DNA analysis
Correlative studiesOther: flow cytometry
Correlative studiesOther: pharmacological study
Other Name: pharmacological studiesOther: immunohistochemistry staining method
Optional correlative studies
Other Name: immunohistochemistry
- 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 ]The primary endpoint of this phase II trial is the proportion of confirmed responses (complete response (CR) or partial response (PR)) noted as the objective status and will be considered synonymous with "success" for this study.Response will be evaluated using all cycles of treatment. A CR is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as Disappearance of all evidence of disease. A PR is defined as Regression of measurable disease and no new sites with ≥50% decrease in SPD of up to 6 largest dominant masses; no increase in size of other nodes. The proportion of successes will be estimated by the number of successes divided by the total number of evaluable patients.
- Median Overall Survival Time [ Time Frame: Every 6 months for up to 2 years ]The median overall survival time is defined as the time from registration to death due to any cause. The distribution of survival time will be estimated using the method of Kaplan-Meier.
- Median Progression-free Survival Time [ Time Frame: Every 6 months for up to 2 years ]The median progression-free survival time is defined as the time from registration to progression or death due to any cause. The distribution of progression-free survival will be estimated using the method of Kaplan-Meier. Progression is defined using the Cheson et al. Revised Response Criteria for Malignant Lymphoma as: Any new lesion or increase by ≥50% of previously involved sites from nadir, Appearance of a new lesion(s) > 1.5 cm in any axis, ≥50% increase from nadir in SPD of more than one node, or ≥50% increase in longest diameter of a previously identified node > 1 cm in short axis, Lesions PET positive if FDG-avid lymphoma or PET positive prior to therapy, > 50% increase from nadir in the SPD of any previous lesions, New or recurrent involvement.
- Duration of Response [ Time Frame: Every 6 months for up to 2 years ]Duration of response is defined for all evaluable patients who have achieved a confirmed response as the date at which the patient's objective status is first noted to be a CR or PR to the earliest date progression (PD) is documented. The distribution of duration of response will be estimated using the method of Kaplan-Meier. (CR: Disappearance of all evidence of disease, PR: Regression of measurable disease and no new sites, PD: Any new lesion or increase by ≥50% of previously involved sites from nadir).
- 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 ]
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): NCT01261247
|United States, Arizona|
|Mayo Clinic in Arizona|
|Scottsdale, Arizona, United States|
|United States, Minnesota|
|Rochester, Minnesota, United States, 55905|
|Study Chair:||Patrick Johnston, M.D.||Mayo Clinic|