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 @ 10:13 PM
Ignite Modification Date:
2025-12-24 @ 10:13 PM
NCT ID:
NCT01998035
Eligibility Criteria:
Inclusion Criteria:
* Phase I: Histologically confirmed relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma (WHO criteria), with no accepted curative options.
* Phase II: Relapsed or refractory T-cell lymphoma, including patients with central nervous system (CNS) involvement or lymphomatous meningitis are allowed on study.
* Relapsed or refractory disease following frontline chemotherapy. No upper limit for the number of prior therapies. Patients may have relapsed after prior autologous or allogeneic stem cell transplant.
* Evaluable Disease in the Phase I, and measurable disease for the Phase II.
* Age \> or = 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2.
* Patients must have adequate organ and marrow function.
* Negative urine or serum pregnancy test for females of childbearing potential.
* All females of childbearing potential must use an effective barrier method of contraception during the treatment period and for at least 1 month thereafter. Male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Prior Therapy
* Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier.
* Systemic steroids that have not been stabilized ( ≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs.
* No other concurrent investigational agents are allowed.
* History of allergic reactions to Oral 5-azacitidine or Romidepsin.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Pregnant women.
* Nursing women.
* Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years.
* Patients known to be Human Immunodeficiency Virus (HIV)-positive.
* Patients with active hepatitis A, hepatitis B, or hepatitis C infection.
* Concomitant use of CYP3A4 inhibitors.
* Any known cardiac abnormalities.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01998035
Study Brief:
Protocol Section:
NCT01998035