search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Een farmacokinetiek studie van vincristine bij het gelijktijdig gebruik van anti-schimmelmedicijnen bij kinderen die behandeld worden voor acute lymfatische leukemie (ALL).


- candidate number9400
- NTR NumberNTR2877
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2011
- Secondary IDs36660 ABR
- Public TitleEen farmacokinetiek studie van vincristine bij het gelijktijdig gebruik van anti-schimmelmedicijnen bij kinderen die behandeld worden voor acute lymfatische leukemie (ALL).
- Scientific TitleVincristine and concomitant azole therapy in pediatric acute lymphoblastic leukemia patients. A pharmacokinetic interaction study.
- ACRONYMVCR-Azolen trial
- hypothesisThe aim of this study is to provide evidence based dosing guidelines for vincristine in combination with azoles. Therefore we will study the pharmacokinetics of vincristine with and without concomitant azole therapy in pediatric patients with acute lymphoblastic leukemia.
- Healt Condition(s) or Problem(s) studiedAcute Lymfatic Leukemia (ALL), Children, Pharmacokinetics, Vincristine, Azole therapy
- Inclusion criteria1. Diagnosed with acute lymphoblastic leukemia;
2. Treatment according to DCOG ALL-10-protocol, induction phase and intensification phase for Medium Risk Group patients;
3. Vincristine 1.5 mg/m2 or 2 mg/m2 as iv bolus;
4. Age 1 - < 18 years;
5. Azole group: Azole therapy started at least 5 days before planned VCR treatment (7 days for fluconazole);
6. Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
- Exclusion criteria1. Blood sampling not possible;
2. Patient refusal or parent refusal;
3. Not able to comply with scheduled follow-up;
4. Patients with underlying neurological disease such as Charcot-Marie-Tooth disease or Guillain-Barre syndrome;
5. Patients with underlying Down syndrome.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-jul-2011
- planned closingdate1-jul-2013
- Target number of participants40
- InterventionsNo intervention, observation of blood levels of vincristine.
- Primary outcomePharmacokinetic data of vincristine and the active metabolite M1 in peripheral blood.
- Secondary outcome1. Serum levels of azoles;
2. Vincristine toxicity will be assessed.
- TimepointsSampling will be performed around 2 VCR administrations during induction and intensification phase of the standard treatment of ALL (DCOG-ALL-10 protocol).
Toxicity will be assessed during 4 weeks following the last sampling.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD. N.K.A. Eijkelenburg, van
- CONTACT for SCIENTIFIC QUERIESMD, PhD C.M. Zwaan
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Stichting Go4Children
- PublicationsN/A
- Brief summaryVincristine (VCR) is an important component in the treatment of acute lymphoblastic leukemia (ALL) in children. Proper dosing of vincristine is required to maximize disease control while avoiding toxicity. Peripheral and autonomic neuropathies are the most common side effects which can be life-threatening. Vincristine pharmacokinetics are time- and dose-dependent and considerable intra- and interpatient variation have previously been reported. Vincristine is predominantly metabolized in the liver by the cytochrome P450 (CYP) 3A family of enzymes and eliminated by an efflux pump, P-glycoprotein (P-gp). Inhibition of CYP3A4 by several drugs, such as azole antifungals, could increase vincristine exposure and potentiate the side effects caused by vincristine. Since in paediatric oncology patients azoles are increasingly being used for prophylaxis and treatment of fungal infections, guidelines for the co-administration of vincristine and azole therapy are necessary. The azoles used for antifungal prophylaxis are itraconazole, voriconazole and fluconazole. Several case reports suggest that co-administration of azoles and vincristine lead to increased toxicity, but this has not been studied specifically. It is not known whether these side-effects are related to a higher exposure of vincristine, and to what extent this exposure is increased. Information of the increase in plasma levels of vincristine during concomitant azole therapy may lead to evidence-based dosing guidelines for the effective and safe co-administration of these drugs, assuming that lower dose-levels of vincristine are needed.
- Main changes (audit trail)
- RECORD2-mei-2011 - 4-jul-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl