NL-OMON51961尚未招募3 期
International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine. - ALCL-VB
German Pediatric Oncology Group (GPOH) gGmbH0 个研究点目标入组 10 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
- 0 至 17（—）
入选标准
- •* Stratification into the standard risk group (SR):
- •-Newly diagnosed ALK-positive ALCL
- •-Stage I not completely resected, or stage II or stage III
- •-MDD negative
- •* Age < 18 years
- •* Informed consent of the parents/legal guardians (and assent of the competent
- •child) for study participation and data collection, storage and handling given
- •before study entry
- •* Participation in national / study group's reference pathology
- •* Follow-up for at least 3 years after enrolment is expected
- •* Application of a highly effective contraceptive method (Pearl index <1) in
- •sexually active patients
- •* Application of one intrathecal triple therapy with Methotrexate, Cytarabine
- •and Prednisolone (or Hydrocortisone respectively)
排除标准
- •* Progressive disease during a possible clinically indicated pre-phase
- •treatment before inclusion in the study
- •* Steroids for more than 2 days or chemotherapy pre-treatment before taking the
- •screening sample for MDD
- •* Chemotherapy pre-treatment before start of the study treatment except for
- •-the obligatory initial intrathecal triple therapy with Methotrexate,
- •Cytarabine and Prednisolone (or Hydrocortisone respectively)
- •-a possible clinically indicated pre-phase including up to 5 days of steroids
- •combined with up to 3 doses of Vinblastine (or up to 2 doses of
- •Cyclophosphamide)
- •* Pregnancy or lactation period
- •* Contraindications for the treatment with Vinblastine:
- •-hypersensitivity against VBL or other vinca-alkaloids
- •-leukopenia, other than in the context of the ALCL
- •-severe uncontrolled infection
- •* Other medical, psychiatric, familial or social condition prohibiting
- •treatment according to the protocol
研究者
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