A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma

Completed · Phase 2

Conditions studied: Adult Lymphocyte Depletion Hodgkin Lymphoma, Adult Lymphocyte Predominant Hodgkin Lymphoma, Adult Mixed Cellularity Hodgkin Lymphoma, Adult Nodular Lymphocyte Predominant Hodgkin Lymphoma, Adult Nodular Sclerosis Hodgkin Lymphoma, Recurrent Adult Hodgkin Lymphoma

In brief

This phase II trial studies how well giving panobinostat together with lenalidomide works in treating patients with relapsed or refractory Hodgkin lymphoma. Panobinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Giving panobinostat together with lenalidomide may be an effective treatment for Hodgkin lymphoma

Key facts

Study ID

NCT01460940

Run by

Ohio State University Comprehensive Cancer Center

People needed

24

Starts

2011-10-13

Expected to finish

2016-11-16

Last updated by the study team

2017-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed classical or lymphocyte predominant Hodgkin's lymphoma that is relapsed or refractory after at least one prior chemotherapy; patients with Hodgkin's lymphoma may have one of the following World Health Organization (WHO) subtypes:
• Nodular sclerosis Hodgkin's lymphoma
• Mixed cellularity Hodgkin's lymphoma
• Lymphocyte-rich Hodgkin's lymphoma
• Lymphocyte-deplete Hodgkin's lymphoma
• Nodular Lymphocyte-predominant Hodgkin's lymphoma
• Patients must have relapsed or progressed after at least one prior cytotoxic chemotherapy
• Previous autologous or allogeneic stem cell transplantation is permitted
• Previous treatment with either single agent panobinostat or lenalidomide is permitted
• Absolute neutrophil count (ANC) >= 1200/μL
• Platelets >= 100,000/μl
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit normal (ULN)
• Serum bilirubin =< 1.5 x ULN
• Calculated creatinine clearance >= 60ml/min by Cockcroft-Gault estimation of CrCI
• Measurable Disease must be present either on physical examination or imaging studies; non-measurable disease alone is not acceptable; any tumor mass > 1 cm is acceptable; lesions that are considered non-measurable include the following:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Bone marrow involvement (involvement by non-Hodgkin lymphoma should be noted)
• Baseline multi gated acquisition (MUGA) or echocardiogram (ECHO) must demonstrate left ventricular ejection fraction (LVEF) >= 45%
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2
• Able to provide written informed consent obtained prior to participation in the study and any related procedures being performed

You may not qualify if…

• Patients who are candidates for high dose chemotherapy and autologous stem cell transplantation with curative intent should not be enrolled
• Patients with active central nervous system (CNS) lymphoma
• Use of valproic acid for any medical condition while receiving protocol treatment or within 5 days prior to first panobinostat dose
• Impaired cardiac function or clinically significant cardiac diseases, including any one of the following:
• History or presence of sustained ventricular tachyarrhythmia; (patients with a history of atrial arrhythmia are eligible but should be discussed with Novartis prior to enrollment)
• Any history of ventricular fibrillation or Torsade de Pointes
• Bradycardia defined as heart rate (HR) < 50 beats per minute (bpm); patients with pacemakers are eligible if HR >= 50 bpm
• Screening electrocardiogram (ECG) with a QTc > 450 msec
• Right bundle branch block + left anterior hemiblock (bifascicular block)
• Patients with myocardial infarction or unstable angina =< 6 months prior to starting study drug
• Other clinically significant heart disease (e.g., congestive heart failure [CHF] New York [NY] Heart Association class III or IV, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen)
• Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of panobinostat
• Patients with diarrhea > Common Terminology Criteria for Adverse Events (CTCAE) grade 2
• Other concurrent severe and/or uncontrolled medical conditions (e.g., uncontrolled diabetes or active or uncontrolled infection) including abnormal laboratory values, that could cause unacceptable safety risks or compromise compliance with the protocol
• Patients using medications that have a relative risk of prolonging the QT interval or inducing torsade de pointes if treatment cannot be discontinued or switched to a different medication prior to starting study drug
• Known hypersensitivity to thalidomide or lenalidomide.
• The development of erythema nodosum if characterized by a desquamating rash while taking thalidomide or similar drugs
• Pregnant or breastfeeding females
• Patients with known positivity for human immunodeficiency virus (HIV) or hepatitis B or C; baseline testing for HIV and hepatitis C is not required. Patients who are seropositive because of hepatitis B virus vaccine are eligible.
• Concurrent use of other anti-cancer agents or treatments
• Patients with any significant history of non-compliance to medical regimens or unwilling or unable to comply with the instructions given to him/her by the study staff

Where it is running

• Washington University — St Louis, Missouri, United States
• The Ohio State University Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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