None listed
Conditions
Interventions
Drug : ? Azacitidine is administered by subcutaneous injection (75 mg/m2/day) from Day 1 to Day 5 and repeated at 4-week intervals.
? Lenalidomide is administered orally at a dose of 20 mg once daily
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with mature T-cell lymphoma of T-cell origin according to the 2016 WHO diagnostic criteria who have experienced at least one relapse or refractory state ? Angioimmunoblastic T-cell lymphoma ? Follicular helper T-cell lymphoma ? Peripheral T-cell lymphoma with follicular helper T-cell type ? Peripheral T-cell lymphoma, not otherwise specified ? Hepatosplenic T-cell lymphoma 2. Age 20–90 at the time of diagnosis 3. ECOG activity 0–2 4. Presence of one or more measurable lesions (long axis 1.5 cm or larger) (however, for hepatosplenic T-cell lymphoma, enrollment is possible if hepatomegaly or splenomegaly is above the normal range or if invasion is confirmed by bone marrow biopsy) 5. Cardiac function adequate for chemotherapy: LVEF = 45% on echocardiography or MUGA 6. Renal function adequate: Serum Cr = 1.5 mg/dL or creatinine clearance according to the Cockcroft-Gault formula = 50 mL 7. Adequate liver function: ALT = 2.5 times the upper limit of normal (however, if liver involvement is present, = 5 times the upper limit of normal), Total bilirubin = 2 times the upper limit of normal (however, if liver involvement is present, = 3 times the upper limit of normal) 8. Adequate hematological findings: Absolute neutrophil count = 1,500/µL, Platelets = 100,000/µL (however, if bone marrow involvement is present, Absolute neutrophil count = 500/µL, Platelets = 50,000/µL) 9. Written consent to the clinical trial participation consent form 10. Ability to comply with the trial visit schedule and other requirements of the protocol 11. For women of childbearing age, a negative pregnancy test result 12. Women of childbearing age must use an effective method of contraception (i.e., hormonal contraceptives, intrauterine devices, spermicide-assisted diaphragms, spermicide-assisted condoms, or abstinence) during the clinical trial period and for 3 months thereafter; men must use an effective method of contraception during the clinical trial period and for 3 months thereafter. 13. Life expectancy = 90 days (3 months) 14. Hepatitis B or C clinical trial subjects: Hepatitis B carriers taking prophylactic antivirals may be selected, and subjects with inactive Hepatitis C (normal aminotransferase) may also be selected.
Exclusion criteria
Exclusion criteria: 1. Non-Hodgkin lymphoma of a different specific subtype 2. History of receiving chemotherapy for Hodgkin or other non-Hodgkin lymphoma within the last 5 years 3. History of being diagnosed with active cancer within the last 3 years. (However, completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer can be registered) 4. Uncontrolled Hepatitis B (however, asymptomatic HBsAg-positive or anti-HBc Ab-positive individuals receiving prophylactic antiviral therapy such as entecavir or tenofovir are eligible for enrollment) 5. History of chronic Hepatitis C (however, if HCV IgG-positive, enrollment is eligible if the HCV-RNA quantitative test is negative) 6. History of human immunodeficiency virus (HIV) infection 7. Severe disease or medical condition 8. Congestive heart failure = NYHA class 3 9. Acute coronary syndrome (newly onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months of study enrollment 10. History of major neurological or psychiatric disease, including dementia or epilepsy 11. Severe chronic obstructive pulmonary disease with hypoxemia 12. Cerebrovascular disease (including transient cerebral ischemia) within 3 months of study enrollment 13. Non-healing wounds, ulcers, or bone fractures 14. Uncontrolled active infection (viral, bacterial, or fungal infection) 15. Concomitant administration of other investigational agents currently in clinical trials 16. Previous history of hypersensitivity to the investigational drug 17. History of major surgery or severe trauma within 21 days prior to administration of the investigational drug. Open tissue biopsy within 7 days prior to administration of the investigational drug 18. In men who have not undergone vasectomy, if the partner plans to become pregnant during the study period, or if, even if not planning, is unable to use a medically recognized method of contraception (partner's sterilization, partner's intrauterine device, interstitial contraception, diaphragm, or condom combination) 19. Women and men of childbearing age who are pregnant or breastfeeding, or who do not intend to use appropriate contraception during the study period 20. Cases of central nervous system involvement 21. Cases of prior azacitidine and lenalidomide combination therapy: provided that enrollment is possible if each drug was administered alone or in combination with other drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall Response rate;Overall survival;Event-free survival;Progression Free Survival;Safety and Efficacy | — |
Countries
Korea, Republic of
Contacts
Public ContactJayeon Kim
Samsung Medical Center
Outcome results
None listed