Loading clinical trials...

Panobinostat in Treating Patients With Relapsed or Refractory Non-Hodgkin Lymphoma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01261247•Mayo Clinic

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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); NOTE: relapsed NHL is defined as NHL that relapses after at least one prior therapy and does not have available curative therapy; refractory NHL is defined as NHL that has progressed or not responded to most recent therapy and has had at least one prior therapy and have no available curative therapies
•Measurable disease by CT or MRI or the CT portion of the PET/CT: must have at least one lesion that has a single diameter of \>= 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 upper limit of normal (ULN) or if total bilirubin is \> 1.5 x ULN the direct bilirubin must be normal
•AST =\< 3 x ULN
•Albumin \> 3.0 g/dl
+34 more criteria

Exclusion Criteria

•Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer
•Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first panobinostat treatment
•Candidate for known standard therapy for the patient's disease that is potentially curative
•Uncontrolled infection requiring ongoing antibiotics

Locations (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Mayo Clinic

Rochester, Minnesota, United States

Key Dates

Start Date

January 17, 2011

Primary Completion Date

May 9, 2016

Completion Date

December 2, 2019

Last Updated

May 24, 2022

Enrollment

ACTUAL participants

Conditions

Adult Nasal Type Extranodal NK/T-cell LymphomaAnaplastic Large Cell LymphomaAngioimmunoblastic T-cell LymphomaExtranodal Marginal Zone B-cell Lymphoma of Mucosa-associated Lymphoid TissueHepatosplenic T-cell LymphomaNodal Marginal Zone B-cell LymphomaPeripheral T-cell LymphomaPost-transplant Lymphoproliferative DisorderRecurrent Adult Burkitt LymphomaRecurrent Adult Diffuse Large Cell LymphomaRecurrent Adult Lymphoblastic LymphomaRecurrent Adult T-cell Leukemia/LymphomaRecurrent Grade 1 Follicular LymphomaRecurrent Grade 2 Follicular LymphomaRecurrent Grade 3 Follicular LymphomaRecurrent Mantle Cell LymphomaRecurrent Mycosis Fungoides/Sezary SyndromeRecurrent Small Lymphocytic LymphomaSmall Intestine LymphomaSplenic Marginal Zone LymphomaWaldenstrom Macroglobulinemia

Interventions

panobinostat

DRUG

laboratory biomarker analysis

OTHER

western blotting

GENETIC

DNA analysis

GENETIC

flow cytometry

OTHER

pharmacological study

OTHER

immunohistochemistry staining method

OTHER

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

NCT07388563

Lymphoma, T Cell, PeripheralT-cell Lymphoma+4 more

View study

RECRUITINGPHASE3

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

NCT06561048

Peripheral T-Cell Lymphoma, Not Otherwise SpecifiedAngioimmunoblastic T-cell Lymphoma+5 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 24, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma

Donor Stem Cell Transplant With Treosulfan, Fludarabine, and Total-Body Irradiation for the Treatment of Hematological Malignancies

Brigatinib in Pediatric and Young Adult Patients With ALK+ ALCL, IMT or Other Solid Tumors

Study of Pembrolizumab (MK-3475) in Combination With Romidepsin

Study of CAR-T Cells Expressing CD30 and CCR4 for r/r CD30+ HL and CTCL