Angioimmunoblastic T-cell Lymphoma Clinical Trial
Official title:
An Open-label Phase 2 Study of Intravenous Bortezomib and Oral Panobinostat (LBH589) in Adult Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or NK/T-cell Lymphoma After Failure of Conventional Chemotherapy
Verified date | June 2014 |
Source | Singapore General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Singapore: Health Sciences Authority |
Study type | Interventional |
The purpose of this study is to determine whether intravenous Bortezomib combined with oral Panobinostat (LBH589) are effective in treating adult patients with relapsed/refractory peripheral T-cell lymphoma or NK/T-cell lymphoma after the failure of conventional chemotherapy.
Status | Completed |
Enrollment | 25 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed PTCL NOS, angioimmunoblastic T-cell lymphoma, extranodal NK/T-cell lymphoma nasal type, enteropathy- type T-cell lymphoma, hepatosplenic T-cell lymphoma, ALCL (ALK-1 negative), or patients with ALK 1 expressing ALCL (ALK-1 positive) who have relapsed disease after ASCT - Age =21 years - Written informed consent - Progressive disease following at least one systemic therapy or refractory to at least one prior systemic therapy - Measurable disease according to the IWC criteria and/or measurable bone marrow disease by flow cytometry or morphology - Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 - Absolute neutrophil count of =1000 × 10(9)cells/L - Serum potassium =3.8 mmol/L and magnesium =0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria) - Negative urine or serum pregnancy test on females of childbearing potential - All females of childbearing potential and males must use an effective barrier method of contraception during the treatment period and for at least 1 month thereafter. Exclusion Criteria: - Chemotherapy or immunotherapy within 3 weeks of study entry - Concomitant use of any other anti-cancer therapy - Concomitant use of any other investigational agent - Any known cardiac abnormalities such as: - Congenital long QT syndrome; - QTcF interval >480 milliseconds (msec); - A myocardial infarction within 12 months of study entry; - Other significant ECG abnormalities including 2nd atrio-ventricular (AV) block type II, 3rd degree AV block, or bradycardia (ventricular rate < 50 beats/ min). - An ECG recorded at screening showing significant ST depression (ST depression of =2 mm, measured from isoelectric line to the ST segment at a point 60 msec at the end of the QRS complex). If in any doubt, the patient should have a stress imaging study and, if abnormal, angiography to define whether or not CAD is present; - Congestive heart failure (CHF) that meets New York Heart Association (NYHA) Class II to IV definitions and/or ejection fraction <40% by MUGA scan or <50% by echocardiogram and/or MRI; - A known history of sustained ventricular tachycardia (VT), ventricular fibrillation (VF), Torsade de Pointes, or cardiac arrest unless currently addressed with an automatic implantable cardioverter defibrillator (AICD); - Hypertrophic cardiomyopathy or restrictive cardiomyopathy from prior treatment or other causes (if in doubt, see ejection fraction criteria above); - Any cardiac arrhythmia requiring anti-arrhythmic medication; - Serum potassium <3.8 mmol/L or serum magnesium <0.85 mmol/L (electrolyte abnormalities can be corrected with supplementation to meet inclusion criteria) - Concomitant use of drugs that may cause a prolongation of the QTcF - Concomitant use of CYP3A4 inhibitors - Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule - Concomitant use of warfarin due to a potential drug interaction - Clinically significant active infection - Known infection with human immunodeficiency virus (HIV) - Patient has known clinically active hepatitis B or C - Previous extensive radiotherapy involving =30% of bone marrow (e.g., whole pelvis, half spine), excluding patients who have had total body irradiation as part of a conditioning regimen for stem cell transplant - Major surgery within 2 weeks of study entry - Peripheral neuropathy or neuropathic pain of Grade 2 or worse - Platelet count <50 × 109 cells/L or platelet count <30 × 109 cells/L if bone marrow disease involvement is documented - Serum creatinine >2.0 × ULN - Patients who are pregnant or breast-feeding - Patient has known hypersensitivity to any components of bortezomib (such as boron, mannitol), or panobinostat |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Centre | Seoul | |
Malaysia | Hospital Universiti Kebangsaan Malaysia ( HUKM ) | Kuala Lumpur | |
Malaysia | Subang Jaya Medical Centre | Subang Jaya | Selangor |
Singapore | National Cancer Center | Singapore | |
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
Singapore General Hospital |
Korea, Republic of, Malaysia, Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Objective Response Rate | 1 year | No | |
Secondary | Time to response, Duration of response, Progression-free survival, Overall survival, Safety and tolerability, Changes in disease-related symptoms and ECOG performance status. | 1 year | Yes |
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