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

Not Applicable

Completed

Conditions: <p>Ciprofloxacin, cartilage damage, toxicity, acute lymphoblastic leukemia (ALL), children Ciprofloxacine, kraakbeenschade, veiligheid, acute lymfatische leukemie (ALL), kinderen</p>
10024324

Registration Number: NL-OMON24330

Lead Sponsor: Erasmus Medical Center

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 124

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

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)

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>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.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Change 21-07-2014: Document clinical musculoskeletal complaints according to the CTCAE grading system at the time points as of the MRI-assessment.</p><br>