- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01460940
A Phase II Trial of Panobinostat and Lenalidomide in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University
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Ohio
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Columbus, Ohio, United States, 43210
- The Ohio State University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
- Females of childbearing potential (FCBP)† must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL within 10 - 14 days and again within 24 hours prior to starting Cycle 1 of lenalidomide (prescriptions must be filled within 7 days as required by RevAssist) and must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before she starts taking lenalidomide. FCBP must also agree to ongoing pregnancy testing. Men must agree to use a latex condom during sexual contact with a FCBP even if they have had a successful vasectomy.
- Able to take aspirin (81 or 325 mg) daily as prophylactic anticoagulation (patients intolerant of aspirin or at increased risk of venous thrombosis may use warfarin or low molecular weight heparin)
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Lenalidomide and Panobinostat
In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.
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Administered orally Monday, Wednesday, Friday of every week for 4 weeks.
A cycle is define as 28 days.
Other Names:
Lenalidomide will be administered orally daily on days 1-21.
Lenalidomide will not be given on days 22-28.
A cycle is define as 28 days.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine the Overall Response Rate (ORR), Including Complete Responses (CR) and Partial Responses (PR)
Time Frame: up to 24 months
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Overall response rate (CR + PR) will be determined using the International response criteria with combined panobinostat and lenalidomide in patients with relapsed or refractory Hodgkin's lymphoma.
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up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Assess the Safety and Tolerability of Combined Lenalidomide and Panobinostat in Patients With Previously Treated Hodgkin's Lymphoma.
Time Frame: up to 24 months
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Safety and tolerability will be assessed for patients using the NIH-NCI Common Terminology Criteria (CTCAE) version 4.0
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up to 24 months
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Progression-free Survival in Patients With Previously Treated Hodgkin's Lymphoma Receiving Combined Lenalidomide and Panobinostat
Time Frame: 3-5 years
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Determined from the date of start of therapy to death from any cause or censored at the last date the patient is known to be alive
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3-5 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Kristie Blum, MD, Ohio State University
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Lenalidomide
- Histone Deacetylase Inhibitors
- Panobinostat
Other Study ID Numbers
- OSU-10049
- NCI-2011-03323 (Registry Identifier: Clinical Trial Reporting Program (CTRP))
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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