ALL SCTped 2012 FORUM - Allogeneic Stem Cell Transplantation in Children and Adolescents with Acute Lymphoblastic Leukaemia
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,108
- 试验地点
- 61
- 主要终点
- Stratum 1: Overall Survival (OS)
研究概览
简要总结
Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non-total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or an HLA matched donor (MD).
Stratum 1 – MSD/MD: To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire cohort (question 3 and 5).
Stratum 1 – MSD/MD in age-group 2-4 years: To explore incidence of adverse events of special interest (AESIs) and short-term overall survival and event free survival in the entire cohort receiving TBI/VP16 conditioning regimen.
Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 years 至 64 years（18-64 Years, 0-17 Years）
- 接受健康志愿者
- 否
入选标准
- •All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- •Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years
- •Indication for allogeneic HSCT
- •Complete remission (CR) before SCT
- •Written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form”
- •No pregnancy
- •No secondary malignancy
- •No previous HSCT
- •HSCT is performed in a study participating centre
排除标准
- •Patients who do not fulfil the inclusion criteria
- •Non-Hodgkin Lymphoma
- •Whole protocol and/or its essential parts are refused either by the patient himself/herself or the respective legal guardian
- •No consent is given for saving and propagation of anonymous medical data for study reasons
- •Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion e.g.: malformation syndromes, cardiac malformations, metabolic disorders; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection
- •Karnofsky / Lansky score < 50%
- •Subjects unwilling or unable to comply with the study procedures
结局指标
主要结局
Stratum 1: Overall Survival (OS)
Stratum 1: Overall Survival (OS)
Stratum 2: Event Free Survival (EFS)
Stratum 2: Event Free Survival (EFS)
次要结局
- Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)
- Stratum 1: EFS
- Stratum 2: OS
- Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM)
- Stratum 1 and 2: Cumulative Incidence of Relapse
- Stratum 1 and 2: Toxicity: acute and late
- Stratum 1 and 2: Secondary malignancies
研究者
Christina Peters
Scientific
St. Anna Childrens Cancer Research Institute GmbH