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De veiligheid van ciprofloxacine op het kraakbeen in de behandeling van kinderen met acute lymfatische leukemie (ALL).


- candidate number13342
- NTR NumberNTR3623
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-sep-2012
- Secondary IDs41786 ABR
- Public TitleDe veiligheid van ciprofloxacine op het kraakbeen in de behandeling van kinderen met acute lymfatische leukemie (ALL).
- Scientific TitleSkeletal complications of prophylactic ciprofloxacin in the treatment of pediatric ALL.
- ACRONYMCipro MRI trial
- hypothesisTo determine the musculoskeletal safety of standard prophylactic treatment with ciprofloxacin and co-administered glucocorticoids in pediatric patients with acute lymphoblastic leukemia (ALL).
- Healt Condition(s) or Problem(s) studiedSafety, Acute Lymfatic Leukemia (ALL), Children, Ciprofloxacin, Cartilage damage
- Inclusion criteria1. >= 8 to <19 years;
2. Diagnosed with acute lymphoblastic leukemia;
3. Treated according to DCOG ALL-11 protocol;
4. Patients who will receive ciprofloxacin as antimicrobial prophylaxis as defined in the DCOG ALL-11 protocol (15 mg/kg/dose BID).
- Exclusion criteria1. Patients needing general anesthesia to undergo MRI;
2. Children with Down syndrome or other underlying syndromes;
3. Patients unable to undergo MRI due to claustrophobia;
4. Patients with underlying skeletal disorders, including prior fractures of the knees;
5. Patients with (juvenile rheumatoid) arthritis;
6. Patients with metallic implants and foreign bodies in and around the knee joint (although they may be MRI compatible; image artefacts).
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2012
- planned closingdate1-jan-2020
- Target number of participants124
- Interventions2-3 MRIs will be taken of both knees. If cartilage damage is observed, the patient will undergo 1 or 2 additional MRIs.
- Primary outcomeThe main study endpoint is cartilage damage as determined by MRI, compared to a baseline MRI. The amount of important structural components of cartilage (e.g. collagen and glycosaminoglycans) will be measured and mapped quantitatively, for a sensitive and objective quantitative outcome measure of cartilage quality.
- Secondary outcomeClinical complaints concerning musculoskeletal system scored according to CTCAE grading system.
- Timepoints1. Baseline MRI: Within first week of diagnosis of ALL;
2. Second MRI: After 8 weeks (▒1 wk) of ciprofloxacin exposure;
3. In medium risk and high risk (ALL-11 protocol grading): Within 2 weeks after discontinuation of ciprofloxacin treatment;
4. If cartilage damage is present: 1 MRI yearly up to one year after discontinuation ALL treatment.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES R. Hoogendijk
- CONTACT for SCIENTIFIC QUERIESMD, PhD C.M. Zwaan
- Sponsor/Initiator Erasmus Medical Center, Rotterdam, Princess Maxima Center for Pediatric Oncology
- Funding
(Source(s) of Monetary or Material Support)
Kinderen Kankervrij (KiKa), Go4Children
- PublicationsN/A
- Brief summaryCiprofloxacin has been associated with skeletal safety concerns and is therefore formally contra-indicated (with some exceptions) in patients <18 years of age. During the treatment of ALL, patients receive ciprofloxacin for microbiological prophylaxis. Currently, therapeutic doses of ciprofloxacin are used for prophylaxis due to a lack of information on optimal dosing in the prophylactic setting. The drug is given for prolonged periods of time due to recurrent neutropenia and increased risk of infections. However the musculoskeletal safety of ciprofloxacin has not been studied in this setting. Irreversible cartilage toxicity has been observed in animal studies, especially in weight baring joints. The incidence of reported clinical complains of the musculoskeletal system in children treated with quinolones varies between 0-23%. In addition, patients are simultaneously treated with glucocorticoids, which are known to induce osteonecrosis and osteopenia. Hence this combination might result in synergistic skeletal toxicity in these patients.
- Main changes (audit trail)Amendement 01 (21-07-2014)
- We changed the study design from a prospective longitudinal study to a retrospective observational study
- Addition of a healthy control group
- Number of MRI scans is changed to one MRI after treatment

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 na´ve

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)

Target number of participants = 124 (62 patients and 62 healthy controls)

Interventions = Patients and their control will undergo a single MRI of the knee. The symptomatic knee (or in absence of symptoms, the dominant knee) will be screened.

Timepoints = after treatment

Primary Outcome = 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 outcome = Document clinical musculoskeletal complaints according to the CTCAE grading system at the time points as of the MRI-assessment

Amendement 02 (05-03-2015)
Addition of the Princess Maxima Center for Pediatric Oncology

Multicenter Trial = Yes
- RECORD20-sep-2012 - 29-sep-2018


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