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

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 354

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Incidence of symptomatic objectified VTE during childhood ALL treatment in the<br /><br>intervention and standard arm during asparaginase treatment.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. Incidence of major bleeding in the intervention and standard arm during<br /><br>asparaginase treatment.<br /><br>2. Incidence of the clinically relevant non-major bleeding and minor bleeding<br /><br>in the intervention and standard arm during asparaginase treatment.<br /><br>3. Incidence of composite of asymptomatic and symptomatic objectified VTE<br /><br>during childhood ALL treatment in the intervention and standard arm during<br /><br>asparaginase treatment.<br /><br>4. Identification of clinical risk factors and hematological biomarkers in<br /><br>consecutively included patients with and without VTE; to increase insight<br /><br>in the pathogenesis of coagulation disorders during ALL treatment, and to<br /><br>establish a risk model for VTE</p><br>