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 @ 9:46 PM
Ignite Modification Date:
2025-12-24 @ 9:46 PM
NCT ID:
NCT01590732
Eligibility Criteria:
Inclusion Criteria:
* Relapsed or refractory T cell lymphoma (TCL) status including diagnoses of peripheral TCL-not otherwise specified (NOS), angioimmunoblastic TCL, anaplastic large cell lymphoma, hepatosplenic TCL, enteropathy-associated TCL, or mycosis fungoides(MF)/cutaneous TCL with transformation to systemic TCL
* Patients must have received at least one chemotherapy regimen which contained doxorubicin
* At least one 1.5 cm bidimensional measurable lesion or bone marrow positivity of TCL
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* Absolute neutrophil count (ANC) \>= 1000 cells/mm3
* Platelets \>= 80,000 cells/mm3 if baseline bone marrow negative for TCL involvement and platelets \>= 20,000 cells/mm3 if baseline bone marrow positive for TCL involvement
* Bilirubin =\< 2 x upper limits of normal (ULN) (Gilbert's =\< 3 x upper limit of normal \[ULN\])
* Creatinine =\< 1.5 x ULN
* Alanine aminotransferase (ALT) and aminotransferase (AST) =\< 3 x ULN
* Negative pregnancy test for females of childbearing potential within 7 days prior to start of treatment. Patients of reproductive potential must follow accepted birth control methods which include hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence during treatment and for 3 months after completion of treatment
* Voluntarily signed Institutional Review Board (IRB) approved informed consent document (ICD) before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
Exclusion Criteria:
* History of another malignancy not in remission for at least 2 years (yrs) (except non-melanoma skin cancer, stage 0 melanoma, localized prostate cancer, cervical cancer in situ)
* Known active Central Nervous System (CNS) lymphoma
* Ejection fraction (EF) of \< 40%, myocardial infarction (MI) within past 3 months, uncontrolled angina, severe uncontrolled ventricular arrthymias, or electrocardiogram (ECG) evidence of acute ischemia
* Grade 3 infection within 2 weeks of first dose romidepsin plus ICE
* Pregnant or lactating
* Receipt of another investigational drug within 14 days of enrollment
* Patients with previous hypersensitivity reactions to the study drugs and components (ex: podophyllum and povidone)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01590732
Study Brief:
Protocol Section:
NCT01590732