EUCTR2022-002793-91-DE进行中（未招募）1 期
Prospective phase I/II trial of an individualized peptide vaccine in pediatric and AYA patients with metastasized fusion-driven sarcomas following standard treatment - Pervision
niversity Hospital Tuebingen0 个研究点目标入组 23 人开始时间: 2023年1月31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
- 23
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
- 性别
- All
入选标准
- •Confirmed metastatic fusion-driven sarcoma (rhabdomyo-, Ewing- and synovial sarcoma, age = 2 to < 40 years) in complete remission (CR) or partial response (PR) after first therapy phase (e.g. neoadjuvant chemotherapy)
- •Access to whole exome sequencing and RNAseq data of the gene fusion (fusion-breakpoint RNA sequence) (by participation in INFORM, MASTER, HEROES-AYA or comparable programs).
- •Successful design and production of the patient-individual vaccine cocktail
- •Patients have reached first or second complete or stable partial remission including local therapy of the remaining residua (PRplus) at the end of cytotoxic treatment.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 14
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 8
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Non-CR or progressive PR at the end of adjuvant and/or maintenance cytotoxic treatment (during screening phase)
- •Age < 2 or = 40 years
研究者
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