Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2025-12-24 @ 10:50 PM
NCT ID:
NCT00865969
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00865969
Study Brief:
Protocol Section:
NCT00865969