Status:
COMPLETED
Study of Bortezomib and Panobinostat in Treating Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or NK/T-cell Lymphoma
Lead Sponsor:
Singapore General Hospital
Conditions:
Peripheral T-cell Lymphoma (Not Otherwise Specified)
Angioimmunoblastic T-cell Lymphoma
Eligibility:
All Genders
21+ years
Phase:
PHASE2
Brief Summary
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 ly...
Detailed Description
Peripheral T-cell lymphoma (PTCL) and NK/T-cell lymphoma are uncommon diseases that are prevalent in Asia. They are associated with poor prognosis when treated with conventional chemotherapeutic regim...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00901147
Start Date
November 1 2009
End Date
January 1 2014
Last Update
June 27 2014
Active Locations (5)
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1
Hospital Universiti Kebangsaan Malaysia ( HUKM )
Kuala Lumpur, Kuala Lumpur, Malaysia, 56000
2
Subang Jaya Medical Centre
Subang Jaya, Selangor, Malaysia, 47500
3
National Cancer Center
Singapore, Singapore, 169608
4
Singapore General Hospital
Singapore, Singapore, 169608