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:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT01796002
Eligibility Criteria:
Inclusion Criteria:
1. Males and females of 18 years of age to 80 years of age.
2. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
3. Able to adhere to the study visit schedule and other protocol requirements.
4. Patients with histologically proven peripheral T-cell lymphoma (PTCL), not previously treated; the following subtypes as defined by the World Health Organization (WHO) classification (2008;2011) may be included, whatever the Ann Arbor stage (I - IV):
a. Nodal types: i. PTCL, not otherwise specified ii. Angioimmunoblastic T-cell lymphoma iii. Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK)-negative type
b. Extra-nodal types: i. Enteropathy-associated T-cell lymphoma ii. Hepato-splenic T-cell lymphoma iii. Subcutaneous panniculitis-like T-cell lymphoma iv. Primary cutaneous gamma-delta T-cell lymphoma v. Primary cutaneous cluster of differentiation 8 positive (CD8+) aggressive epidermotropic lymphoma vi. Primary cutaneous cluster of differentiation 4 positive (CD4+) small/medium T-cell lymphoma
c. Other non classifiable peripheral T-cell lymphoma
5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
6. Negative pregnancy test for Females of ChildBearing Potential (FCBP)
7. Female patients of child bearing potential must use an effective method of birth control (i.e. hormonal contraceptive, intrauterine device, diaphragm with spermicide, condom with spermicide or abstinence) during treatment period and 1 month thereafter; Males must use an effective method of birth control during treatment period and 3 months thereafter.
8. Life expectancy of ≥ 90 days (3 months).
Exclusion Criteria:
1. Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from participating in the study.
2. Any condition that confounds the ability to interpret data from the study.
3. Other types of lymphomas, e.g. B-cell lymphoma
4. The following types of T cell lymphomas:
1. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
2. Extranodal T-cell/Natural Killer (NK)-cell lymphoma, nasal type
3. Anaplastic large cell lymphoma, ALK-positive type
4. Cutaneous T cell lymphoma (mycosis fungoid, Sézary syndrome)
5. Primary cutaneous cluster of differentiation antigen 30 positive (CD30+) T-cell lymphoproliferative disorder
6. Primary cutaneous anaplastic T-cell lymphoma
5. Previous treatment for PTCL with immunotherapy or chemotherapy except for short-term corticosteroids (duration of ≤ 8 days) before randomization
6. Previous radiotherapy for PTCL except if localized to one lymph node area
7. Patients planned for autologous or allogeneic transplant as consolidation in first line
8. Central nervous system -meningeal involvement
9. Contraindication to any drug contained in the chemotherapy regimen,
10. Subjects with HIV positivity
11. Subjects with active hepatitis B or C. Chronic carriers of Hepatitis B virus (HBV) without HBV DNA positive blood are eligible. Subjects with non-active hepatitis C (with normal transaminases) are eligible.
12. Any of the following laboratory abnormalities, except if secondary to the lymphoma:
1. Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5 x 109/L),
2. Platelet count \< 100,000/mm3 (100 x 109/L), or \< 75,000/mm3 if bone marrow is involved,
3. Serum Aspartate Aminotransferase (ASAT/AST) or Alanine Aminotransferase (ALAT/ALT) ≥ 3.0 x Upper Limit of Normal (ULN),
4. Serum total bilirubin \> 2 x ULN, except in case of hemolytic anemia,
5. K+ and Mg2+ levels \< Lower Limit of Normal (LLN), except if corrected per protocol guidance before beginning the romidepsin infusion
13. Serum creatinine \> 2.0 x ULN
14. Prior history of malignancies other than lymphoma (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix or breast or untreated prostatic cancer without any plan for a treatment) unless the patient has been free of the disease for ≥ 3 years
15. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing the informed consent form
16. Any known cardiac abnormalities such as:
1. Patients with congenital long QT syndrome
2. Corrected QT interval \> 480 msec (using the Fridericia formula)
3. Myocardial infarction within 6 months of cycle 1 day 1
4. History of or concomitant significant cardiovascular disease
5. Ejection fraction \<45% by multigated acquisition (MUGA) scan or by echocardiogram;
17. Concomitant use of drugs that may cause a significant prolongation of the corrected QT interval (QTc)
18. Patients who have received more than 200 mg/m2 doxorubicin
19. Concomitant use of strong CYP3A4 inhibitors
20. Concomitant use of therapeutic warfarin due to a potential drug interaction. Use of a low dose of warfarin or another anticoagulant to maintain patency of venous access port and cannulas is permitted.
21. Clinically significant active infection
22. Use of any standard or experimental anti-cancer drug therapy within 28 days of the initiation (Day 1) of study drug
23. Pregnant or lactating females or women of childbearing potential not willing to use an adequate method of birth control for the duration of the study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01796002
Study Brief:
Protocol Section:
NCT01796002