TropicALL study; Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a randomized controlled trial - TropcALL study

Stichting Kinderoncologie Nederland0 个研究点目标入组 354 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•a. Written informed consent for TropicALL randomisation has been given
•b. Newly diagnosed patients with T-lineage or precursor-B lineage ALL (patients with mature B-ALL are not eligible)
•c. Age between * 366 days and < 19 years
•d. Diagnosis ALL confirmed by DCOG laboratory
•e. Patient should be treated in a Dutch Childhood Oncology Centre

•a. Patients who are already being treated with anticoagulation upon screening (for other indications)
•b. Patients with a heparin allergy (or for one of its components), a recent history (within 6 months) of heparin-induced thrombocytopenia (HIT) or any other contraindication listed in the local labeling of LMWH
•c. Patients with active bleeding or high risk for bleeding contraindicating anticoagulant therapy (Thrombocytopenia is not an exclusion criterion)
•d. Patients with renal insufficiency (glomerular filtration rate (GFR) < 30 ml/min/1.73m2)
•e. Patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
•f. Patients with stage 2 hypertension defined as blood pressure confirmed > 99th percentile + 5 mmHg
•g. Patients with any condition that, as judged by the investigator, would place the patient at increased risk of harm if he/she participated in the study.
•h. Patients who are included in the ALL-11 IVIG study
•i. Patients with Ph-positive ALL (documented presence of t(9;22)(q34;q11) and/or of the BCR/ABL fusion transcript). These patients will be transferred to the EsPhALL protocol in induction according to the guidelines of the EsPhALL protocol.

发起方

Stichting Kinderoncologie Nederland