No registrations found.
ID
Source
Brief title
Health condition
AML
Sponsors and support
Erasmus MC-Sophia Children's Hospital
POB 2060
3000 CB Rotterdam
Netherlands
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
1. 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.
Background summary
N/A
Study objective
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.
Study design
For all patients every 4 weeks PB will be samples for MRD. Only for inv(16) patients this will be done every 8 weeks.
Intervention
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.
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
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
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL3350 |
| NTR-old | NTR3482 |
| Other | METC Erasmus MC : 2012-01 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |