NCT00901147

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 lymphoma or NK/T-cell lymphoma after the failure of conventional chemotherapy.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2009

Typical duration for phase_2

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

June 27, 2014

Status Verified

June 1, 2014

Enrollment Period

4.2 years

First QC Date

May 11, 2009

Last Update Submit

June 26, 2014

Conditions

Peripheral T-cell Lymphoma (Not Otherwise Specified)Angioimmunoblastic T-cell LymphomaExtranodal NK/T-cell Lymphoma Nasal TypeEnteropathy- Type T-cell LymphomaHepatosplenic T-cell LymphomaAnaplastic Large Cell Lymphoma (ALCL) (ALK-1 Negative)Relapsed ALCL (ALK-1 Positive) Post Autologous Transplant

Keywords

t-cell lymphomaperipheral t-cell lymphomank/t-cell lymphoma, nasal typebortezomibvelcadepanobinostatLBH589bhistone deacetylase inhibitorproteasome inhibitor

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    1 year

Secondary Outcomes (1)

  • 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

Study Arms (1)

panobinostat and bortezomib

EXPERIMENTAL

Oral Panobinostat and intravenous bortezomib

Drug: panobinostat and bortezomib

Interventions

panobinostat and bortezomibDRUG

oral panobinostat 30 mg 3 times per week AND intravenous bortezomib 1.3mg/m2 on days 1,4,8,11 per cycle

Also known as: LBH589B, Velcade
panobinostat and bortezomib

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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.

You may not qualify if:

  • 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;
  • Concomitant use of drugs that may cause a prolongation of the QTcF
  • Concomitant use of CYP3A4 inhibitors
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Hospital Universiti Kebangsaan Malaysia ( HUKM )

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

Location

Subang Jaya Medical Centre

Subang Jaya, Selangor, 47500, Malaysia

Location

National Cancer Center

Singapore, 169608, Singapore

Location

Singapore General Hospital

Singapore, 169608, Singapore

Location

Samsung Medical Centre

Seoul, Seoul, 135-710, South Korea

Location

Related Publications (1)

  • Tan 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: 26688485DERIVED

MeSH Terms

Conditions

Lymphoma, T-CellImmunoblastic LymphadenopathyLymphoma, Extranodal NK-T-CellEnteropathy-Associated T-Cell LymphomaLymphoma, Large-Cell, AnaplasticLymphoma, T-Cell, Peripheral

Interventions

PanobinostatBortezomib

Condition Hierarchy (Ancestors)

Lymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphadenopathy

Intervention Hierarchy (Ancestors)

Hydroxamic AcidsHydroxylaminesAminesOrganic ChemicalsHydroxy AcidsCarboxylic AcidsIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBoronic AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsBoron CompoundsPyrazinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Yeow Tee Goh, MBBS MMed

    Singapore General Hospital

    PRINCIPAL INVESTIGATOR

  • Darryl Tan, MBBS MMED

    Singapore General Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 11, 2009

First Posted

May 13, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

June 27, 2014

Record last verified: 2014-06

Locations

MY(2)KR(1)SG(2)