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临床试验/KCT0003956
KCT0003956进行中（未招募）未知

Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin CHOP (Ro-CHOP) versus CHOP in subjects with Previously Untreated Peripheral T-Cell Lymphoma

Samsung Medical Center0 个研究点目标入组 30 人开始时间: 待定最近更新:
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适应症

试验速览

阶段
未知
状态
进行中（未招募）
入组人数
30
研究概览入排标准研究者记录与标识符相似试验

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
18(Year) 至 80(Year)（—）
性别
All

入选标准

  • •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 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, 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 CD8+ aggressive epidermotropic lymphoma
  • •vi. Primary cutaneous CD4+ small/medium T-cell lymphoma
  • •c. Other non classifiable peripheral T-cell lymphoma
  • •5. 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).

排除标准

  • •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:
  • •a. Adult T-cell lymphoma/leukemia (HTLV-1 related T-cell lymphoma)
  • •b. Extranodal T-cell/NK-cell lymphoma, nasal type
  • •c. Anaplastic large cell lymphoma, ALK-positive type
  • •d. Cutaneous T cell lymphoma (mycosis fungoides, Sézary syndrome)
  • •e. Primary cutaneous CD30+ T-cell lymphoproliferative disorder
  • •f. 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 without HBV DNA positive blood are eligible after advice from hepatologist and initiation of prophylactic treatment if needed. Subjects with non-active hepatitis C (with normal transaminases) are eligible. Patients with HBc Ab+/ HBs Ab+/ HBs Ag- and HBV DNA- should be referred to an hepatologist and a prophylactic treatment should be initiated if needed
  • •12. Any of the following laboratory abnormalities, except if secondary to the
  • •a. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L),
  • •b. Platelet count < 100,000/mm3 (100 x 109/L), or < 75,000/mm3 if bone marrow is involved,
  • •c. Serum SGOT/AST or SGPT/ALT = 3.0 x upper limit of normal (ULN),
  • •d. Serum total bilirubin > 2 x ULN, except in case of hemolytic anemia,
  • •e. K+ and Mg2+ levels < 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:
  • •a. Patients with congenital long QT syndrome
  • •b. Corrected QT interval > 480 msec (using the Fridericia formula)
  • •c. Myocardial infarction within 6 months of cycle 1 day 1
  • •d. History of or concomitant significant cardiovascular disease
  • •e. Ejection fraction <45% by MUGA scan or by echocardiogram;
  • •17. Concomitant use of drugs that may cause a significant prolongation of the 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 femal

研究者

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