The 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.
ID
Bron
Verkorte titel
Aandoening
AML
Ondersteuning
Erasmus MC-Sophia Children's Hospital
POB 2060
3000 CB Rotterdam
Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Whether 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.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
The 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.
Onderzoeksopzet
For all patients every 4 weeks PB will be samples for MRD. Only for inv(16) patients this will be done every 8 weeks.
Onderzoeksproduct en/of interventie
Patients 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.
Publiek
Erasmus MC-Sophia Children's Hospital<br>
POB 2060
C.M. Zwaan
Rotterdam 3000 CB
The Netherlands
+31 (0)10 7036691/6130
c.m.zwaan@erasmusmc.nl
Wetenschappelijk
Erasmus MC-Sophia Children's Hospital<br>
POB 2060
C.M. Zwaan
Rotterdam 3000 CB
The Netherlands
+31 (0)10 7036691/6130
c.m.zwaan@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3350 |
| NTR-old | NTR3482 |
| Ander register | METC Erasmus MC : 2012-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |