Acute lymphoblastic leukemia MedDRA version: 17.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864
Conditions
Interventions
Trade Name: Fraxiparine
Product Name: Fraxiparine
Pharmaceutical Form: Solution for injection
Sponsors
Dutch Childhood Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All patients between 1 and 19 years of age with primary ALL, who are eligible for and treated within the DCOG ALL-11 or ALL-12 study protocol. Are the trial subjects under 18? yes Number of subjects for this age range: 354 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 2 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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 without informed consent d. Patients with active bleeding or high risk for bleeding contraindicating anticoagulant therapy (Thrombocytopenia is not an exclusion criterion) e. Patients with renal insufficiency (glomerular filtration rate (GFR) 99th percentile + 5 mmHg h. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of thromboprophylaxis with high prophylactic dose LMWH as compared with standard care without systemic thromboprophylaxis in children treated for primary ALL during asparaginase treatment.; Secondary Objective: 1. To assess the safety of thromboprophylaxis using high prophylactic dose LMWH as compared with standard of care without systemic thromboprophylaxis in children treated for newly diagnosed ALL, by assessment of the incidence of major bleeding during asparaginase treatment. 2. To assess whether ALL treatment with thromboprophylaxis using high prophylactic dose LMWH as compared with standard of care without systemic thromboprophylaxis influences complete remission and (overall or disease-free) survival rates of childhood ALL 3. To identify clinical risk factors or hematological biomarkers in ALL patients with and without symptomatic objectified VTE; to increase insight in the pathogenesis of coagulation disorders during ALL treatment and to establish a risk model for VTE. ;Primary end point(s): Incidence of symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm during asparaginase treatment.;Timepoint(s) of evaluation of this end point: During interim analyses and also at the end of this protocol, expected in 2019. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Incidence of major bleeding in the intervention and standard arm during asparaginase treatment. 2. Incidence of the clinically relevant non-major bleeding and minor bleeding in the intervention and standard arm during asparaginase treatment. 3. Incidence of composite of asymptomatic and symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm during asparaginase treatment. 4. ALL treatment outcomes by assessment of complete remission and (overall or disease-free) survival rates in the intervention and standard arm; 5. Identification of clinical risk factors and hematological biomarkers in consecutively included patients with and without VTE; to increase insight in the pathogenesis of coagulation disorders during ALL treatment, and to establish a risk model for VTE ;Timepoint(s) of evaluation of this end point: During interim analyses and also at the end of this protocol, expected in 2019. | — |
Countries
Netherlands
Contacts
Public ContactTrial and Data Center
Dutch Childhood Oncology Group
Outcome results
None listed