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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT03617432
Eligibility Criteria:
Inclusion Criteria:
1. Histopathology / cytology diagnosed as peripheral T cell lymphoma (PTCL) according to WHO 2016 classification criteria（NK/T cell lymphoma and ALK positive anaplastic large cell lymphoma excluded）including:Peripheral T-cell lymphoma, NOS，Angioimmunoblastic T-cell lymphoma，Anaplastic large-cell lymphoma, ALK negative，Enteropathy-associated T-cell lymphoma，Hepatosplenic T-cell lymphoma，Subcutaneous panniculitis T-cell lymphoma，Mycosis fungoides，Other T-cell lymphoma that investigators consider to be appropriate to be enrolled;
2. Patients have received CHOPE regimen for 2 cycles therapy and achieve PR or SD;
3. Patients should have at least one evaluable foci ( lymph nodes with diameter≥1.5cm, or evaluable skin foci);
4. Age 18-70 years, male or female;
5. ECOG performance status 0-2;
6. Absolute neutrophil count ≥1.5×109/L, platelet ≥75×109/L, Hb ≥ 90g/L;
7. ALT and serum creatinine \<1.5 times of normal maximum;
8. Life expectancy no less than 3 months;
9. Willing to sign the Informed Consent Form.
Exclusion Criteria:
1. NK/T cell lymphoma or ALK positive anaplastic large cell lymphoma;
2. Female patients in lactation or pregnancy, Childbearing female or male patients unwilling to take contraceptive measures;
3. QTc elongation with clinical significance ( male\> 450ms, female\> 470ms), ventricular tachycardia, atrial fibrillation, cardiac conducting blockage, myocardial infarction within 1 year, congestive heart failure, symptomatic coronary heart disease that requires treatment;
4. Patients have undergone organ transplantation;
5. Patients received symptomatic treatment for bone marrow toxicity within 7 days prior to enrollment;
6. Patients with active hemorrhage;
7. Patients with or with history of thrombosis, embolism, cerebral hemorrhage, or cerebral infarction;
8. Patients with active infection or continuous fever within 14 days prior to enrollment;
9. Had major organ surgery within 6 weeks prior to enrollment;
10. Impaired liver function ( Total bilirubin \> 1.5 times of normal maximum, ALT/AST\> 2.5 times of normal maximum, for patients with infiltrative liver disease ALT/AST\> 5 times of normal maximum), impaired renal function (serum creatinine\> 1.5 times of normal maximum);
11. Patients with mental disorders or those do not have the ability to consent;
12. Patients with drug abuse, long term alcoholism that may impact the results of the trial;
13. Patients with invasion of central nervous system ;
14. Non-appropriate patients for the trial according to the judgment of the investigators.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03617432
Study Brief:
Protocol Section:
NCT03617432