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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24742

Enrollment

300

Registered

2012-06-17

Start date

2012-08-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML

Interventions

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.

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactC.M. Zwaan

Dept. of Pediatric Oncology-Hematology Erasmus MC-Sophia Children's Hospital POB 2060

c.m.zwaan@erasmusmc.nl+31 (0)10 7036691/6130

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)