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Prospective study of quantitative molecular minimal residual disease (MRD) monitoring in pediatric acute myeloid leukemia (AML).


- candidate number12901
- NTR NumberNTR3482
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR17-jun-2012
- Secondary IDs2012-01 METC Erasmus MC
- Public TitleProspective study of quantitative molecular minimal residual disease (MRD) monitoring in pediatric acute myeloid leukemia (AML).
- Scientific TitleProspective study of quantitative molecular minimal residual disease (MRD) monitoring in pediatric acute myeloid leukemia (AML).
- ACRONYMQMRD in AML
- hypothesisThe hypothesis is that all patients with rising RT-qPCR MRD levels of specific genetic markers in pediatric AML patients in CR1 invariably will develop overt clinical relapse.
- Healt Condition(s) or Problem(s) studiedAcute Myeloid Leukemia (AML)
- Inclusion criteria1. AML, established according to the WHO-classification, and treated according to a collaborative group AML protocol;
2. One of the following genetic aberrations documented at diagnosis:
A. t(8;21), RUNX1-RUNX1T1;
B. inv(16), CBFb/MYH11;
C. t(9;11), MLL-AFP9;
D. t(10;11) , MLL-AFP10;
E. NPM1 mutation;
F. FLT3-ITD mutation.
3. ≤ 18 years old at initial diagnosis;
4. Life expectancy >=6 weeks;
5. A PCR target with a sensitivity of at least 10-4 needs to be available;
6. Molecular remission (< 5 x 10-4) at the end of consolidation;
7. Able to comply with scheduled follow-up;
8. Written informed consent from patients or from parents or legal guardians for minor patients, according to local law and regulations.
- Exclusion criteriaA potential subject who meets any of the following criteria will be excluded from participation in this study:
1. Down syndrome leukemia;
2. Acute promyelocytic leukemia (APL);
3. Therapy-related AML.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2012
- planned closingdate1-aug-2016
- Target number of participants300
- InterventionsPatients will be followed with monthly peripheral blood samples for quantative MRD monitoring with RT-qPCR form end of treatment in Cr1 until 18 months later or to hematological relapse.
- Primary outcomeWhether all newly diagnosed pediatric AML patients with specific genetic subtypes (for which a sensitive quantatative MRD marker is available) with rising MRD-values (RT-qPCR) will eventually develop relapse.
- Secondary outcome1. To study the kinetics of rising RT-qPCR levels, and the time to overt relapse, and relate this to the various genetic abnormalities, with the aim to assess the most appropriate time-interval between PB-sampling for the various genetic subcategories in pediatric AML;
2. To study MRD levels prior to SCT in patients who have relapsed and who have received standard chemotherapy re-induction for haematological relapse;
3. To set-up a network of laboratories to implement serial MRD-assessment;
4. To implement quality control between laboratories participating in this network.
- TimepointsFor all patients every 4 weeks PB will be samples for MRD. Only for inv(16) patients this will be done every 8 weeks.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. PhD. C.M. Zwaan
- CONTACT for SCIENTIFIC QUERIESMD. PhD. C.M. Zwaan
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital, Children Oncology Center Rotterdam (KOCR)
- Funding
(Source(s) of Monetary or Material Support)
Celgene
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD17-jun-2012 - 6-jul-2012


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