To determine the musculoskeletal safety of standard prophylactic treatment with ciprofloxacin and co-administered glucocorticoids in pediatric patients with acute lymphoblastic leukemia (ALL)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24330

Enrollment

124

Registered

2012-09-20

Start date

2012-12-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ciprofloxacin, cartilage damage, toxicity, acute lymphoblastic leukemia (ALL), children Ciprofloxacine, kraakbeenschade, veiligheid, acute lymfatische leukemie (ALL), kinderen

Interventions

A 3 Tesla whole-body MRI scanner will be used. MRI will be performed of one knee. This is the symptomatic knee, or in absence of symptoms the dominant knee. The total examination time will be approxim

Eligibility

Inclusion criteria

Inclusion criteria: Patients: - Patients treated for ALL according to DCOG ALL-10 or ALL-11 protocol. - Patients who received ciprofloxacin as antimicrobial prophylaxis as defined in the DCOG ALL-10 or ALL-11 protocol - Age =8 years at time of enrolment in this study - Prophylactic ciprofloxacin treatment ceased for 6 months Control group - Age =8 years at time of enrolment in this study - No history of cartilage or bone problems - Long term ciprofloxacin naive

Exclusion criteria

Exclusion criteria: Patients: - Patients currently under treatment with ciprofloxacin - Patients needing general anesthesia to undergo MRI - Children with Down syndrome or other underlying syndromes - Patients unable to undergo MRI due to claustrophobia - Patients with underlying skeletal disorders, including prior fractures of the knees - Patients with (juvenile rheumatoid) arthritis - Patients with metallic implants and foreign bodies in and around the knee joint (although they may be MRI compatible; image artefacts) - Contraindications for MRI (e.g. pacemaker) Control group: - Needing general anesthesia to undergo MRI - Children with Down syndrome or other underlying syndromes - Children unable to undergo MRI due to claustrophobia - Children with underlying skeletal disorders, including prior fractures of the knees - Children with (juvenile rheumatoid) arthritis - Children with metallic implants and foreign bodies in and around the knee joint (although they may be MRI compatible; image artefacts) - Contraindications for MRI (e.g. pacemaker)

Design outcomes

Primary

Measure	Time frame
Change 21-07-2014: To determine the long-term musculoskeletal safety of standard prophylactic treatment with ciprofloxacin (and co-administered glucocorticoids/chemotherapy) in pediatric patients with ALL treated according to protocol DCOG ALL-10 or ALL-11, based on cartilage damage compared to a healthy prophylactic ciprofloxacin naive peer group.	—

Secondary

Measure	Time frame
Change 21-07-2014: Document clinical musculoskeletal complaints according to the CTCAE grading system at the time points as of the MRI-assessment.	—

Contacts

Public ContactRaoull Hoogendijk

Erasmus MC / Princess Maxima Center for pediatric oncology

r.hoogendijk@prinsesmaximacentrum.nl31 6 5280 3132

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)