europathy caused by vincristine in children with leukemia: comparing one-hour infusions with short-term infusions

Phase 1

• Conditions: Pediatric oncology, acute lymphoblastic leukemia, nephroblastoma, medulloblastoma, low-grade glioma, Hodgkin lymphoma, rhabdomyosarcoma; MedDRA version: 18.0Level: LLTClassification code 10001690Term: ALLSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2014-001561-27-NL
• Lead Sponsor: VU university medical center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-06-30
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

•age between 2 and 19 years.
•treated for cancer according to a treatment protocol which includes at least 6 administrations of VCR of which 4 are administered within a maximum period of 6 weeks;
•diagnosed with a cancer diagnosis of which the Iincidence in the Netherlands is of more than 5 diagnosed patients per year
•written informed consent

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 language.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified