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Phase 2 N=41 Treatment

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

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

Enrolled (actual)
41
Serious AEs
82.9%
Results posted
May 2018
Primary outcome: Primary: Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status — 0.21 proportion of CR or PR patients

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
panobinostat (Drug); laboratory biomarker analysis (Other); western blotting (Genetic); DNA analysis (Genetic); flow cytometry (Other); pharmacological study (Other); immunohistochemistry staining method (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Mayo Clinic
Primary completion
May 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Proportion of Confirmed Responses Defined to be a CR or PR Noted as the Objective Status
0.21
SECONDARY
Median Overall Survival Time
14.9
SECONDARY
Median Progression-free Survival Time
3.1
SECONDARY
Duration of Response
19.7

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

Eligibility 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 = = 2 cm or tumor cells in the blood >= 5 x 10^9/L; skin lesions can be used if the area is >= 2 cm in at least one diameter and photographed with a ruler
  • The following disease types are eligible: transformed lymphomas: diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma grade III; precursor B lymphoblastic leukemia/lymphoma; mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; precursor T-lymphoblastic leukemia/lymphoma; primary cutaneous anaplastic large cell lymphoma; anaplastic large cell lymphoma - primary systemic type; small lymphocytic lymphoma/chronic lymphocytic leukemia; follicular lymphoma, grades 1, 2; extranodal marginal zone B-cell lymphoma of MALT type; nodal marginal zone B-cell lymphoma; splenic marginal zone B-cell lymphoma; peripheral T cell lymphoma, unspecified; anaplastic large cell lymphoma (T and null cell type); lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); CNS lymphoma; post transplant lymphoproliferative disorders; mycosis fungoides/Sezary syndrome; primary effusion lymphoma; blastic NK-cell lymphoma; adult T-cell leukemia/lymphoma; extranodal NK/T-cell lymphoma, nasal type; enteropathy-type T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma - primary cutaneous type
  • For lymphoplasmacytic lymphoma patients without measurable lymphadenopathy, measurable disease can be defined by both of the following criteria: bone marrow lymphoplasmacytosis with > 10% lymphoplasmacytic cells or aggregates, sheets, lymphocytes, plasma cells, or lymphoplasmacytic cells on bone marrow biopsy and quantitative IgM monoclonal protein > 1,000 mg/dL
  • ANC >= 1000/uL
  • Hgb >= 9 g/dl
  • PLT >= 75,000/uL
  • Total bilirubin = 1.5 x ULN the direct bilirubin must be normal
  • AST = 3.0 g/dl
  • Creatinine = = LLN and = = LLN
  • Clinically euthyroid; patients are permitted to receive thyroid hormone supplements to treat underlying hypothyroidism
  • Baseline MUGA or ECHO must demonstrate LVEF >= the lower limit of the institutional normal
  • Ability to understand and the willingness to sign a written informed consent document
  • Willingness to return to Mayo Clinic
  • Life expectancy >= 12 weeks
  • Willingness to provide blood and tissues samples for research studies as required by the protocol
  • Negative pregnancy test done = 20mg of prednisone per day (or equivalent)
  • Persistent toxicities >= grade 2 from prior chemotherapy or biological therapy regardless of interval since last treatment
  • Patients with congenital long QT syndrome
  • History or presence of sustained ventricular tachyarrhythmia (patients with a history of atrial arrhythmia are eligible but should be discussed with the study PI prior to enrollment)
  • Any history of ventricular fibrillation or torsade de pointes
  • Bradycardia defined as HR = 50 bpm
  • Screening ECG with a QTcFredericia (QTcF) > 450 msec
  • Right bundle branch block + left anterior hemiblock (bifascicular block)
  • Patients with myocardial infarction or unstable angina = CTCAE Grade 2, malabsorption syndrome or small bowel resection) that would preclude use of oral medications
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months
  • Any severe and/or uncontrolled medical conditions or other conditions that, in the treating physician's opinion, could adversely impact their ability to participate in the study; patients on chronic oxygen therapy, those with liver disease such as cirrhosis, chronic hepatiti
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01261247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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