No registrations found.
ID
Source
Brief title
Health condition
TropicALL, ALL, Acute Lymphoblastic Leukemia, Thromboprophylaxis, Children Low-molecur-weight heparin, venous thrombosis.
TropicALL, ALL, Acute Lymfoblastische Leukemie, tromboprofylaxe, kinderen, laag-moleculair-gewicht heparine (LMWH), veneuze trombose
Sponsors and support
Stichting Kinderoncologie Nederland (SKION)
Intervention
Outcome measures
Primary outcome
Incidence of symptomatic objectified VTE during childhood ALL treatment in the intervention and standard arm.
Secondary outcome
1. 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
Background summary
Not applicable
Study objective
Primary 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.
Study design
Eligibility 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
Intervention
In 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)
CH Ommen, van
ErasmusMC Sophia Children's Hospital
Rotterdam 3015CN
The Netherlands
010 7036691
c.vanommen@erasmusmc.nl
CH Ommen, van
ErasmusMC Sophia Children's Hospital
Rotterdam 3015CN
The Netherlands
010 7036691
c.vanommen@erasmusmc.nl
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 12 study protocol.
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) < 30 ml/min/1.73m2)
f. Patients with hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4351 |
| NTR-old | NTR4707 |
| Other | EudraCT : 2014-003303-30 |