RecruitingPhase 4NCT02670564

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

Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)


Sponsor

Swiss Pediatric Oncology Group

Enrollment

1,000 participants

Start Date

Apr 1, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

Pharmacogenomics (PG) offers the opportunity to individualize treatment according to patient genetic variations which influence activity of enzyme metabolizing or acting in the pathway of prescribed chemotherapy drugs. This add-on research aims to prospectively investigate variations in several candidate genes related to all types of chemotherapeutic drugs and TBI used in the main related study NCT 01949129, THE ALL SCTped FORUM study for their potential role as predictive biomarkers of PK variability and outcome of myeloablative therapy for pediatric patients receiving an allogeneic hematopoietic stem cell transplantation in acute lymphoblastic leukemia.


Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how differences in genes (pharmacogenomics) affect how children with acute lymphoblastic leukemia (ALL — a type of blood cancer) respond to drugs used during stem cell transplants, to help personalize treatment and reduce dangerous side effects. **You may be eligible if...** - You are a child or young person diagnosed with acute lymphoblastic leukemia (ALL) - You are scheduled to receive a stem cell (bone marrow) transplant as part of your treatment - You are enrolled in or eligible for the main ALL SCTped FORUM trial - Your parent or guardian has provided informed consent **You may NOT be eligible if...** - You have a known genetic condition that would interfere with the study's genetic analysis - You or your guardian are unwilling to provide genetic samples - You do not meet the age or diagnosis criteria for the main trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICPharmacogenomics

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.

OTHERBusulfan 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


Locations(4)

Hôpital Cantonal de Genève, Département de Pédiatrie

Geneva, Cansearch Laboratory, Switzerland

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

Basel, Switzerland

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

Geneva, Switzerland

Universitäts-Kinderspital

Zurich, Switzerland

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NCT02670564


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