TropicALL study
- Conditions
- Acute lymphoblastic leukemiaMedDRA version: 17.1 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-003303-30-NL
- Lead Sponsor
- Dutch Childhood Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 354
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
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
g. Patients with stage 2 hypertension defined as blood pressure confirmed > 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method