CTIS2023-505990-34-00进行中（未招募）1 期
Hyper-CVAD/MA for high-risk aggressive B-cell lymphomas: a single-centre academic phase II trial (HYPERION)
Karolinska University Hospital0 个研究点目标入组 183 人开始时间: 2023年11月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 183
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •Written informed consent according to ICH-GCP guidelines, Age = 18 and < 65 years, Eligible to receive at least 4 courses of R-Hyper-CVAD/R-MA per investigator determination (a compound clinical judgement based on all available information, in which the clinical performance, comorbidity, biological age, the patient’s social situation and lymphoma status are considered.), Aggressive, untreated, de novo CD20+ aggressive B-cell lymphoma, including: Diffuse large B-cell lymphoma (NOS, GCB, non-GCB or ABC); Large B-cell lymphoma with 11q aberration; Primary diffuse large B-cell lymphoma of the testis; Primary cutaneous diffuse large B-cell lymphoma, leg type; Intravascular large B-cell lymphoma; HHV-8 and EBV-negative primary effusion-based lymphoma; EBV-positive diffuse large B-cell lymphoma, NOS; High-grade B-cell lymphoma, NOS; High-grade B-cell lymphoma with MYC and BCL2 rearrangements; High-grade B-cell lymphoma with MYC and BCL6 rearrangements; Primary mediastinal B-cell lymphoma; T cell/histiocyte-rich B-cell lymphoma; Follicular lymphoma grade 3B; Lymphomatoid granulomatosis grade 3; Mediastinal gray-zone lymphoma; Aggressive B-cell lymphoma, NOS or unclassifiable, At least one of four, as per protocol defined, high-risk criteria must be fufilled, Women of child-bearing potential, only after using a acceptable effective method of contraception (defined in the study protocol) during treatment and for six months after completion of treatment., Sexually active male participants must agree to use barrier prevention (condom) to ensure that embryos/fetuses are not exposed to study drugs via sperm, during treatment and for six months after completion of treatment; non-pregnant, fertile female partners to male participants are also recommended to use an acceptable method of birth control to avoid accidental pregnancy.
排除标准
- •Pregnant or breast-feeding mother, Evidence of significant, uncontrolled concomitant disease(s) that could affect compliance with the protocol or interpretation of results, Previous chemotherapy for any malignancy, Estimated glomerular filtration rate <60 ml/min (unless due to lymphoma), Impaired liver function, defined as serum total bilirubin > 2 x ULN (> 3 x ULN if Gilbert’s syndrome) or serum ALT and AST ? 3 x ULN (unless due to lymphoma), Unstable angina pectoris, cardiac infarction within 3 months or congestive heart failure New York Heart Association Class II-IV (unless due to lymphoma), Psychiatric disorder or dementia which make the patient unable to give an informed consent and/or adhere to the schedule, TdT-positive lymphoma, CD34-positive lymphoma, Previous organ transplantation, Men and women of reproductive potential not agreeing to use an acceptable method of birth control (defined in study protocol) during treatment and for six months after completion of treatment, Excluded diagnoses: CD20 negative lymphoma; Primary CNS lymphoma; Mantle cell lymphoma, including blastic/pleiomorphic types; Transformed lymphoma; Plasmablastic lymphoma; Lymphoblastic lymphoma; Post-transplant lymphoproliferative disorder; Burkitt leukaemia (=25% Burkitt cells in bone marrow); Burkitt lymphoma, Previous or concomitant diagnosis of another hematological malignancy, Previous or concomitant diagnosis of another malignancy which is likely to cause death within 3 years
研究者
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