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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT02445404
Eligibility Criteria:
Inclusion Criteria:
1. Age 19-65 years
2. Informed consent
3. Subject able to adhere to the study visit schedule and other protocol requirements.
4. Histologically proven Peripheral T-cell Lymphoma,No prior chemotherapy for the treatment of Peripheral T-cell Lymphoma It includes the following subtypes.
* PTCL, not otherwise specified
* Angioimmunoblastic T-cell lymphoma
* Anaplastic large cell lymphoma, ALK-negative type
* Enteropathy-associated T-cell lymphoma
* Hepato-splenic T-cell lymphoma
* Subcutaneous panniculitis-like T-cell lymphoma
* Primary cutaneous gamma-delta T-cell lymphoma
* Primary cutaneous CD8+ aggressive epidermotropic lymphoma
* Other non classifiable T-cell Lymphoma
5. Performance status (ECOG) 0,1 or 2
6. A negative pregnancy test prior to treatment must be available both for pre-menopausal women
7. Female of childbearing potential (FCBP) must: contraceptive methods (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) while on IP; and for 3 months following the last dose of IP.Male subjects must practice true abstinence or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions, and for 3 months following IP discontinuation.
8. life expectancy≥90day(3months)
Exclusion Criteria:
1. Other serious medical illnesses or psychiatric disorders
2. Any state that the confusion in the interpretation of test result.
3. Other type lymphoma ex) B-cell lymphoma
4. Other type T-cell lymphoma
* Adult T-Cell Leukemia/Lymphoma
* NK/T-cell Lymphoma, Nasal Type
* ALK-Positive Anaplastic Large-Cell Lymphoma
* Cutaneous Tcell lymphoma
* primary cutaneous CD30+ lympho- proliferative disorder
* primary cutaneous Anaplastic T cell lymphoma
5. Previously treated for PTCL(Except for a short period before randomization of corticosteroids (a period of not more than 8 days)
6. Previous radiation therapy
7. CNS involvement.
8. If the contraindication to chemoherapy
9. Subject has known historical or active infection with HIV.
10. BM function: ANC \< 1.5 × 109/L; Platelet count \<100,000/mm2 (100 × 109/L), SGOT/AST or SGPT/ALT ≥ 3.0 x ULN, Bilirubin\> 2 x upper normal value
11. serum creatinine level \> 2.0 x ULN
12. Any other malignancies within the past 3 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
13. MUGA scan \<45%
14. Those who administered doxorubicin exceeding 200 mg / m2
15. Subject has active, uncontrolled bacterial, viral, or fungal infection(s) requiring systemic therapy.
16. Breast-feeding or pregnant female
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
19 Years
Maximum Age:
65 Years
Study:
NCT02445404
Study Brief:
Protocol Section:
NCT02445404