europathy caused by vincristine in children with leukemia: comparing one-hour infusions with bolus injections
Phase 1
- Conditions
- Acute lymphoblastic leukemiaMedDRA version: 19.0Level: LLTClassification code 10001690Term: ALLSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2014-001561-27-BE
- Lead Sponsor
- VU university medical center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
• inclusion in DCOG ALL-11/EORTC-CLG 58081/EsPhALL protocol
• written informed consent;
• age 2-18 years.
Are the trial subjects under 18? yes
Number of subjects for this age range: 88
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion Criteria
• patient or parent refusal
• history of PNP or other pre-existing neurologic conditions before ALL diagnosis;
• pre-existing severe mental retardation;
• having parents/ guardians who are unable to communicate in the Dutch/French language.
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