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A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Peripheral T-cell Lymphoma

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Trial Information

A Multicenter, Open-Label Trial of Belinostat in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma


This is an open-label, multicenter, single arm efficacy and safety study in patients with
relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior
systemic therapy.

Approximately 120 patients will be enrolled. Patients will be treated with 1000 mg/m²
belinostat administered as a 30-minute IV infusion on days 1-5 of every 3-week cycle until
there is disease progression or unmanageable treatment-related toxicities.

The primary study endpoint is objective response rate (ORR) based on the IHP revision IWG
criteria. Safety will be evaluated during the study and for 30 days after the last
administration of study drug. Adverse events and laboratory studies will be graded according
to NCI-CTCAE v. 3.0.

Inclusion Criteria


Inclusion criteria:

- A histologically confirmed diagnosis of PTCL

- Patients must have relapsed or refractory disease after at least one prior systemic
anticancer regimen. Systemic anticancer therapy is defined as chemotherapy or
immunotherapy administered systemically.

- Patients must have at least one site of disease measurable in two dimensions by
computed tomography (CT).

- Age ≥ 18 years.

- Adequate bone marrow, liver, and renal functions.

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2.

- Negative pregnancy test for women of childbearing potential.

Exclusion criteria:

- Relapse within 100 days of autologous or allogeneic bone marrow transplant.

- Prior HDAC inhibitor therapy.

- Co-existing active infection or any medical condition likely to interfere with trial
procedures.

- Severe cardiovascular disease.

- Clinically significant central nervous system disorders with altered mental status or
psychiatric disorders precluding understanding of the informed consent process and/or
completion of the necessary studies.

- Active concurrent malignancy (except adequately treated non-melanoma skin cancer or
carcinoma in situ of the cervix).

- Symptomatic or untreated central nervous system (CNS) metastases.

- Pregnant or breast-feeding women.

- Known infection with HIV, hepatitis B or hepatitis C.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary - Objective response rate

Outcome Time Frame:

December 2010

Safety Issue:

No

Principal Investigator

Peter Brown, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

H:S Rigshospitalet, Department of Hematology, Denmark

Authority:

United States: Food and Drug Administration

Study ID:

PXD101-CLN-19

NCT ID:

NCT00865969

Start Date:

December 2008

Completion Date:

December 2013

Related Keywords:

  • Peripheral T-cell Lymphoma
  • Belinostat
  • peripheral T-cell lymphoma
  • PXD101
  • PTCL
  • HDAC inhibitor
  • histone deacetylase inhibitor
  • Lymphoma
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Peripheral

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Washington University School of MedicineSaint Louis, Missouri  63110
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
Morristown Memorial HospitalMorristown, New Jersey  07962-1956
Massey Cancer CenterRichmond, Virginia  23298-0037
Rush University Medical CenterChicago, Illinois  60612-3824
University of Tennessee Cancer InstituteMemphis, Tennessee  38103
City of Hope National Medical CenterLos Angeles, California  91010
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Saint Louis UniversitySt. Louis, Missouri  63104
Duke University Medical CenterDurham, North Carolina  27710
Northwestern UniversityChicago, Illinois  60611
Cascade Cancer CenterKirkland, Washington  98034-3013
Henry Ford Health SystemDetroit, Michigan  48202
Comprehensive Cancer CenterGlendale, California  91204
Associates in Oncology and HematologyChattanooga, Tennessee  37404
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Northern New Jersey Cancer AssociatesHackensack, New Jersey  07601
New York UniversityNew York, New York  10016
Karmanos Cancer InstituteDetroit, Michigan  48201
Oncology Associates of BridgeportTrumball, Connecticut  06611
Monter Cancer CenterLake Success, New York  11042
Boston University Medical CenterBoston, Massachusetts  02118
New York University Cancer InstituteNew York, New York  10016
Wilshire Oncology Medical Group, IncLaVerne, California  91750
Penn State Hershey Cancer InstituteHershey, Pennsylvania  17033
Avera Cancer CenterSioux Falls, South Dakota  57105
Yale Cancer Center-Section of Medical OncologyNew Haven, Connecticut  06520
Boca Raton Clinical Research AssociatesBoca Raton, Florida  33432
Center for Cancers and Blood DisordersBethesda, Maryland  20817
Bronx River Medical Associates, PCBronx, New York  10467
Erie County Medical Center (Roswell Park)Buffalo, New York  14215
Upstate Medical Univeristy SyracuseSyracuse, New York  13210
Hematology AssociatesBedford, Ohio  44146
Accelerated Community Oncology Reseaerch Network, Inc. (ACORN)Memphis, Tennessee  38138
UT - M. D. Anderson Cancer CenterHouston, Texas  77030
Fred Hutchinson Cancer Research Center - Seattle Cancer Care AllianceSeattle, Washington  98109
Georgia Health Sciences UniversityAugusta, Georgia  30912
Illinois CancerCare, P.C.Bloomington, Illinois  61701
Illinois Cancer Specialists/Cancer Care & Hematology Specialists of ChicagolandNiles, Illinois  60714
St Luke's Cancer CenterBethlehem, Pennsylvania  18015
The UT Health Science Centre at San AntonioSan Antonio, Texas  78229