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| Sponsor: | Singapore General Hospital |
|---|---|
| Information provided by: | Singapore General Hospital |
| ClinicalTrials.gov Identifier: | NCT00901147 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Peripheral T-cell Lymphoma (Not Otherwise Specified) Angioimmunoblastic T-cell Lymphoma Extranodal NK/T-cell Lymphoma Nasal Type Enteropathy- Type T-cell Lymphoma Hepatosplenic T-cell Lymphoma Anaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative) Relapsed ALCL (ALK-1 Positive) Post Autologous Transplant |
Drug: panobinostat and bortezomib |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 25 |
| Study Start Date: | November 2009 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | May 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
panobinostat and bortezomib: Experimental
Oral Panobinostat and intravenous bortezomib
|
Drug: panobinostat and bortezomib
oral panobinostat 30 mg 3 times per week AND intravenous bortezomib 1.3mg/m2 on days 1,4,8,11 per cycle
|
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 regimes. Their long term disease-free survivals are dismal with only 10-30% of patients surviving long term. More intensive regimens including high dose chemotherapy with autologous stem cell transplant have been tried as primary induction treatment, but have not been shown to be beneficial. Given the rarity of PTCL and NK/T-cell lymphoma, much of the literature consists of studies with small sample size and anecdotal case reports. Therefore, no consensus exists on the best therapeutic strategy for either newly diagnosed or relapsed disease. The failure of conventional chemotherapy in this regard suggests that novel therapies including epigenetic approaches and proteasome inhibition should be explored.
Preclinical data of bortezomib and histone deacetylase inhibitors (HDIs) in T-cell and NK/T-cell lymphoma cell lines are encouraging. Bortezomib and HDIs have also separately demonstrated activity in T and NK/T-cell lymphomas in phase II studies, leading to their separate developments in phase III studies. Demonstration of synergism in these 2 agents, in part due to their dependence on overlapping pathways, suggests that they should be explored as a combination, especially when treating a disease with a very unfavourable outcome. The purpose of this phase II study is to assess the efficacy of orally-administered panobinostat, a potent class I/II pan-deacetylase inhibitor with intravenous bortezomib in this patient population.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Any known cardiac abnormalities such as:
Contacts and Locations| Contact: Daryl Tan, MBBS MRCP | 65-63266604 | daryl.tan@sgh.com.sg |
| Contact: Pei Woon ZN Eng, Bsc (hons) | 65-63214627 | eng.pei.woon@sgh.com.sg |
| Singapore | |
| Singapore General Hospital | Recruiting |
| Singapore, Singapore, 169608 | |
| Contact: Daryl Tan, MBBS MRCP 65-97968856 daryl.tan@sgh.com.sg | |
| National Cancer Center | Recruiting |
| Singapore, Singapore, 169608 | |
| Contact: Soon T Lim, MBBS MRCP 65- 64368000 dmomit@nccs.com.sg | |
| National University Hospital | Not yet recruiting |
| Singapore, Singapore, 119074 | |
| Contact: Liang P Koh, MBBS MRCP 65-67724634 Liang_Piu_KOH@nuh.com.sg | |
| Principal Investigator: | Daryl Tan, MBBS MRCP | Singapore General Hospital |
| Study Chair: | Yeow Tee Goh, MBBS MMED | Singapore General Hospital |
More Information
| Responsible Party: | Singapore General hospital ( Daryl Tan/ YT Goh ) |
| Study ID Numbers: | SGH651, SHF/CTG023/2008 |
| Study First Received: | May 11, 2009 |
| Last Updated: | November 10, 2009 |
| ClinicalTrials.gov Identifier: | NCT00901147 History of Changes |
| Health Authority: | Singapore: Health Sciences Authority |
|
t-cell lymphoma peripheral t-cell lymphoma nk/t-cell lymphoma, nasal type bortezomib velcade |
panobinostat LBH589b histone deacetylase inhibitor proteasome inhibitor |
|
Lymphoma, Large B-Cell, Diffuse Neoplasms by Histologic Type Immunoproliferative Disorders Molecular Mechanisms of Pharmacological Action Immune System Diseases Antineoplastic Agents Gastrointestinal Diseases Bortezomib Immunoblastic Lymphadenopathy Enzyme Inhibitors Intestinal Diseases Lymphoma, T-Cell, Peripheral |
Pharmacologic Actions Protease Inhibitors Lymphoma, B-Cell Lymphatic Diseases Neoplasms Digestive System Diseases Therapeutic Uses Lymphoma, T-Cell Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |