Pharmacogenomic approach to improve treatment for pediatric leukemia patients
Allogeneic Stem Cell Transplant for Children and Adolescents With Acute Lymoblastic Leukemia FORUM - Pharmacogenomic Study (add-on Study)
This study is testing if understanding the genetics of children with leukemia can help doctors choose the right chemotherapy drugs to make treatment safer and more effective.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Swiss Pediatric Oncology Group Academic / other |
| Drugs / interventions | chemotherapy, cyclophosphamide, Fludarabine |
| Locations | 4 sites (Geneva, Cansearch Laboratory and 3 other locations) |
| Trial ID | NCT02670564 on ClinicalTrials.gov |
What this trial studies
This research investigates how genetic variations affect the metabolism of chemotherapy drugs used in treating pediatric patients with acute lymphoblastic leukemia undergoing hematopoietic stem cell transplantation. It focuses on the pharmacogenomics of drugs like busulfan and treosulfan, aiming to identify predictive biomarkers that could enhance treatment outcomes and reduce adverse effects. The study is an add-on to a larger trial and seeks to personalize treatment based on individual genetic profiles, potentially leading to safer and more effective therapies.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 18 years old with acute lymphoblastic leukemia in complete remission who are indicated for allogeneic hematopoietic stem cell transplantation.
Not a fit: Patients with non-Hodgkin lymphoma, those with CNS involvement, or those who have had previous stem cell transplants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment regimens for children with acute lymphoblastic leukemia, minimizing adverse effects.
How similar studies have performed: Other studies have shown promise in using pharmacogenomics to tailor cancer treatments, suggesting that this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details. Gender * Both: both female and male participants are being studied Age Limits * Minimum Age: N/A * Maximum Age: age at time of screening less than 18 years old Accepts Healthy Volunteers: no Eligibility Criteria Inclusion Criteria: * Patients with ALL (except for patients with B-ALL) * indication for allogeneic HSCT * complete remission (CR) before HSCT * written consent of the parents (legal guardian) and, if necessary, the minor patient via "Informed Consent Form" * no pregnancy * no secondary malignancy * no previous HSCT * HSCT is performed in a study participating centre Exclusion Criteria: * Non Hodgkin-Lymphoma * ALL with extramedullary involvement with indication for TBI * CNS involvement at the timepoint of screening * Trisomy 21 * The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian * No consent is given for saving and propagation of anonymous medical data for study reasons * Severe concomitant disease that does not allow treatment according to the protocol at the investigator's discretion (e.g. malformation syndromes, cardiac malformations, metabolic disorders) * Karnofsky / Lansky score \< 50% * Subjects unwilling or unable to comply with the study procedures
Where this trial is running
Geneva, Cansearch Laboratory and 3 other locations
- Hôpital Cantonal de Genève, Département de Pédiatrie — Geneva, Cansearch Laboratory, Switzerland (Recruiting)
- Universitäts-Kinderspital beider Basel (UKBB), Onkologie/Hämatologie — Basel, Switzerland (Recruiting)
- HUG Hôpitaux Universitaire de Genève, Unité d'onco-hématologie pédiatrique — Geneva, Switzerland (Recruiting)
- Universitäts-Kinderspital — Zurich, Switzerland (Recruiting)
Study contacts
- Principal investigator: Marc Ansari, MD, PD — Département de Pédiatrie, Hôpital Cantonal de Genève
- Study coordinator: Marc Ansari, MD, PD
- Email: Marc.Ansari@hcuge.ch
- Phone: +41 22 382 47 31
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.