EUCTR2012-001580-68-DE进行中（未招募）1 期
Phase 3 Multi-Center Randomized Study to Compare Efficacy and Safety of Romidepsin¬ CHOP (Ro-CHOP) versus CHOP in patients with Previously Untreated Peripheral T-Cell Lymphoma. - RoCHOP
YSARC0 个研究点目标入组 420 人开始时间: 2013年7月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 420
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Patients must satisfy all following criteria to be enrolled in the study:
- •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 (l-lV):
- •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+ aggresive 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 300
排除标准
- •The presence of any of the following will exclude a patient from enrollment:
- •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 lymphoma:
- •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,
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