KCT0006961尚未招募未知
Multicenter, open label, phase I/II study of azacitidine-CHOP for patients with nodal T-cell lymphoma with T-follicular helper phenotype
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 41
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20?(Year) 至 85?(Year)（—）
- 性别
- All
入选标准
- •1. Treatment-naïve patients with newly diagnosed nodal T-cell lymphoma with T-follicular helper (TFH) phenotype as determined by the following 2016 WHO diagnostic criteria:
- •- Angioimmunoblastic T-cell lymphoma
- •- Follicular helper T-cell lymphoma
- •- Peripheral T-cell lymphoma with follicular helper T-cell type
- •2. 20 to 85 years of age at diagnosis
- •3. ECOG performance status 0–2
- •4. Cardiac function suitable for chemotherapy: LVEF =45% on echocardiography or MUGA
- •5. Appropriate renal function: Serum Cr =2.0mg/dL or eGFR = 30mL/min according to the Cockroft-Gault formula
- •6. Appropriate hepatic function: ALT =2.5x upper limit of normal (ULN) (or =5x ULN in the presence of liver involvement), total bilirubin =2x ULN (or =3x ULN in the presence of liver involvement)
- •7. Appropriate hematologic findings: absolute neutrophil count (ANC) =1,500/µL, platelets =100,000/µL (or ANC =500/µL and platelets =50,000/ µL in the presence of bone marrow involvement)
- •8. Written informed consent to participate in the study
- •9. Capable of following the study visit schedule and other requirements in the protocol
- •10. For women of childbearing potential, a negative pregnancy test
- •11. Women of childbearing potential must use an effective method of contraception (i.e., hormonal contraception, intrauterine device, diaphragm with spermicide, condom with spermicide, or abstinence) during the study period and for 3 months afterward. Men are to use an effective method of contraception during the study period and for 3 months afterward.
- •12. Life expectancy =90 days (3 months)
- •13. Hepatitis B or C infection: Hepatitis B carriers and subjects with inactive hepatitis C infection (normal levels of aminotransferases) are eligible if they take prophylactic antiviral drugs
排除标准
- •1. Other subtypes of non-Hodgkin’s lymphoma
- •2. History of chemotherapy for Hodgkin’s or other non-Hodgkin’s lymphoma in the last 5 years
- •3. History of active cancer diagnosed within the last 3 years (with the exception of completely resected non-melanoma skin cancer, papillary thyroid cancer, carcinoma in situ of cervical cancer or breast cancer, and localized prostate cancer)
- •4. Uncontrolled hepatitis B (with the exception of asymptomatic HBsAg-positive or anti-HBcAb-positive cases receiving antiviral prophylaxis such as entecavir or tenofovir)
- •5. History of chronic hepatitis C (with the exception of HCV IgG positive with a negative HCV-RNA quantification)
- •6. History of human immunodeficiency virus (HIV) infection
- •7. Congestive heart failure (NYHA class =3)
- •8. Acute coronary syndrome (new-onset unstable angina or myocardial infarction) or ventricular tachycardia within 6 months prior to study entry
- •9. History of major neurological or psychiatric illness, including dementia or epilepsy
- •10. Severe chronic obstructive pulmonary disease with hypoxemia
- •11. Cerebrovascular disease within 3 months prior to study entry (including transient cerebral ischemia)
- •12. Unresolved wounds, ulcers, or bone fractures
- •13. Uncontrolled active infections (viral, bacterial, or fungal infections)
- •14. Concurrent use of other experimental drugs under investigation
- •15. Known hypersensitivity to the investigational drugs
- •16. History of major surgery or serious trauma within 21 days prior to study treatment. Open biopsy within 7 days prior to study treatment
- •17. Male subjects who had not undergone a vasectomy and have a partner who plans to become pregnant or are unable to use a medically acceptable method of contraception (partner’s sterilization or intrauterine device placement, or barrier method combined with diaphragm or condom) during the subject’s participation in the study
- •18. Pregnant or breastfeeding women or women of childbearing potential and men who are not willing to use appropriate methods of contraception during the study
- •19. Previously treated for T-cell lymphoma with immunotherapy or chemotherapy, except for short-term corticosteroids (for less than 8 days) prior to selection
- •20. Prior radiotherapy, except for those localized to a single lymph node
- •21. Central nervous system involvement
- •22. Contraindication to any of the drugs included in the chemotherapy
- •23. History of administration of doxorubicin at >200 mg/m²
研究者
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