Status:
COMPLETED
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma
Lead Sponsor:
Spectrum Pharmaceuticals, Inc
Collaborating Sponsors:
Valerio Therapeutics
Conditions:
Peripheral T-cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to assess efficacy and safety of belinostat in participants with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
Detailed Description
This is an open-label, multicenter, single arm efficacy and safety study in participants with relapsed or refractory peripheral T-cell lymphoma, who have failed at least one prior systemic therapy. A...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- A histologically confirmed diagnosis of PTCL
- Participants 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.
- Participants 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 histone deacetylase (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 human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
Exclusion
Key Trial Info
Start Date :
December 15 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 27 2014
Estimated Enrollment :
129 Patients enrolled
Trial Details
Trial ID
NCT00865969
Start Date
December 15 2008
End Date
October 27 2014
Last Update
October 29 2021
Active Locations (117)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
Wilshire Oncology Medical Group, Inc
La Verne, California, United States, 91750
3
Comprehensive Cancer Center
Palm Springs, California, United States, 92262
4
Yale Cancer Center-Section of Medical Oncology
New Haven, Connecticut, United States, 06520