ALL SCTped FORUM - Pharmacogenomic Study (add-on Study)

PHASE4RecruitingINTERVENTIONAL
Enrollment

1,000

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

April 30, 2021

Study Completion Date

April 30, 2026

Conditions
Acute Lymphoblastic Leukemia
Interventions
GENETIC

Pharmacogenomics

"Blood samples (2x5ml EDTA tubes) should be collected just before the start of the conditioning regimen from every patient regardless of therapeutic arm by every centre and stored ≤-20°C Patient should be in remission (MRD negative) for this sampling, otherwise the sample should be taken using a mouth swab/saliva (not intravenously).~For second transplant patients, please provide DNA taken before first transplant or a fresh saliva samples."

OTHER

Busulfan plasma level measurements

"Bu PK analysis after the first dose of IV Bu (+potential subsequent ones).~Blood sampling:~-\>For Bu 4 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 15 min (Time 2), 30 min (Time 3), 1 hour (Time 4) and 4 hour (Time 5) after the end of infusion~-\>For Bu 1 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 1 hour (Time 2), 3 hour (Time 3), 5 hour (Time 4), 7 hour (Time 5) and 11 hour (Time 6) after the end of infusion.~For centers not performing BU TDM, perform Dried Blood Sampling (DBS) analysis:~-\> 0.5ml blood sample should be collected and 5µl spotted onto DBS cards in duplicate. Dry them max 5 hours and then keep in a sealed envelope and store at -80°C, as below"

Trial Locations (4)

1211

RECRUITING

Hôpital Cantonal de Genève, Département de Pédiatrie, Geneva

RECRUITING

HUG Hôpitaux Universitaire de Genève, Unité d'onco-hématologie pédiatrique, Geneva

4056

RECRUITING

Universitäts-Kinderspital beider Basel (UKBB), Onkologie/Hämatologie, Basel

8032

RECRUITING

Universitäts-Kinderspital, Zurich

All Listed Sponsors
collaborator

ALL SCTped Forum

OTHER

lead

Swiss Pediatric Oncology Group

OTHER