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TropicALL study


- candidate number19212
- NTR NumberNTR4707
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR30-jul-2014
- Secondary IDs2014-003303-30  EudraCT
- Public TitleTropicALL study
- Scientific TitleTropicALL study:
Thromboprophylaxis in Children treated for Acute Lymphoblastic Leukemia with Low-molecular-weight heparin: a randomized controlled trial
- ACRONYMDCOG TropicALL study
- hypothesisPrimary 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.
Secondary objectives:
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 the composite of major bleeding or clinically relevant non-major bleeding
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.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Thrombosis, Venous thrombosis, Low molecular weight heparin (LMWH), Children
- Inclusion criteriaAll patients between 1 and 19 years of age with primary ALL, who are eligible for and treated within the DCOG ALL-11 or 12 study protocol.
- Exclusion criteriaa. 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) < 30 ml/min/1.73m2)
f. Patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2014
- planned closingdate
- Target number of participants354
- InterventionsIn the intervention arm, high prophylactic dose LMWH (nadroparin) is subcutaneously injected daily, adjusted to actual body weight with 85 IU anti-Xa/kg with a maximum of 5700 IU anti-Xa daily. Target anti-Xa level: 0.3-0.4 IU/ml)
- Primary outcomeIncidence of symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.
- Secondary outcome1. Incidence of the composite of major bleeding or clinically relevant non-major bleeding in the intervention and standard arm;
2. Incidence of composite of asymptomatic and symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.
3. ALL treatment outcomes by assessment of complete remission and (overall or disease-free) survival rates in the intervention and standard arm;
4. 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
- TimepointsEligibility for the TropicALL study will be evaluated directly after study inclusion in the ALL-11 or 12 study. In ALL-11, inclusion in the TropicALL study will take place within the first week of ALL treatment (day 11 at the latest), and after receiving written informed consent. Randomization will take place on day 11, the day before the first PEG-asparaginase administration (day 12). Randomization of each patient will be performed by a GCP proof randomization computer program at the DCOG trial office.

Non-continuous asparaginase schedule
Induction
- start: day 12 of Induction IA;
continued until: day 54 (in total 43 days) in Induction IA;
(until 14 days after the last PEG-asparaginase administration or 7 days after the last Erwinia asparaginase administration)
Medium Risk Intensification
restart: in week 1 (on day of first asparaginase administration);
continued until: week 29

continuous asparaginase schedule
Induction, Protocol M and Medium Risk intensification
start: day 12 of Induction IA;
continued until week 17 of MR intensification
- Trial web sitewww.skion.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES CH Ommen, van
- CONTACT for SCIENTIFIC QUERIES CH Ommen, van
- Sponsor/Initiator Dutch Childhood Oncology Group (DCOG), Stichting KinderOncologie Nederland (SKION)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD30-jul-2014 - 3-jan-2017


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