Clinical trial · Interventional
Study of Bortezomib and Panobinostat in Treating Patients With Relapsed/Refractory Peripheral T-cell Lymphoma or NK/T-cell Lymphoma
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
NCT00901147CI-TRIAL-00014959completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (7)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative) | — | UNRESOLVED | — |
| Angioimmunoblastic T-cell Lymphoma | Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type | ALIAS | 0.90 |
| Enteropathy- Type T-cell Lymphoma | Enteropathy-Associated T-Cell Lymphoma | ALIAS | 0.90 |
| Extranodal NK/T-cell Lymphoma Nasal Type | Extranodal NK-/T-Cell Lymphoma, Nasal Type | ONTOLOGY_EXACT | 0.90 |
| Hepatosplenic T-cell Lymphoma | Hepatosplenic T-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Peripheral T-cell Lymphoma (Not Otherwise Specified) | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
| Relapsed ALCL (ALK-1 Positive) Post Autologous Transplant | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| panobinostat and bortezomib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- panobinostat and bortezomib
- description
- Oral Panobinostat and intravenous bortezomib
- interventionNames
- Drug: panobinostat and bortezomib
Primary outcomes (1)
- measure
- Objective Response Rate
- timeFrame
- 1 year
Secondary outcomes (1)
- measure
- Time to response, Duration of response, Progression-free survival, Overall survival, Safety and tolerability, Changes in disease-related symptoms and ECOG performance status.
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDTan D, Phipps C, Hwang WY, Tan SY, Yeap CH, Chan YH, Tay K, Lim ST, Lee YS, Kumar SG, Ng SC, Fadilah S, Kim WS, Goh YT; SGH651 Investigators. Panobinostat in combination with bortezomib in patients with relapsed or refractory peripheral T-cell lymphoma: an open-label, multicentre phase 2 trial. Lancet Haematol. 2015 Aug;2(8):e326-33. doi: 10.1016/S2352-3026(15)00097-6. Epub 2015 Jul 7. PMID 26688485