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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT03355768
Eligibility Criteria:
Inclusion Criteria:
* Patients must have histologically confirmed relapsed or refractory aggressive peripheral T-cell lymphoma as defined by 2016 World Health Organization (WHO) criteria (excluding nasal natural killer t-cell (NK-T) and blastic natural killer (NK))
* Patients are required to have no more than 5 lines of prior therapy (with cytoreductive therapy followed by autologous stem cell transplant counting as one line of therapy. Patients are eligible if they have relapsed after prior autologous or allogeneic stem cell transplant
* Measurable Disease
* Age \>18 years
* Eastern Cooperative Oncology Group (ECOG) performance status \<2
* Patients must have adequate organ and marrow function
* Adequate contraception
* Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
* Prior Therapy
* Prior exposure to pralatrexate or a histone deacetylase inhibitor (romidepsin, chidamide, belinostat, or vonrinostat)
* 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 to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs.
* No other concurrent investigational agents are allowed.
* Central nervous system metastases, including lymphomatous meningitis
* Uncontrolled intercurrent illness
* Pregnant women
* Nursing women
* Current malignancy or history of a prior malignancy
* Patient known to be Human Immunodeficiency Virus (HIV)-positive
* Active Hepatitis A, Hepatitis B, or Hepatitis C infection
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT03355768
Study Brief:
Protocol Section:
NCT03355768