Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Busulfan plasma level measurements | Other | — | UNRESOLVED |
| Pharmacogenomics | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Total body irradiation (TBI)
- description
- The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses. Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
- interventionNames
- Genetic: Pharmacogenomics
- type
- EXPERIMENTAL
- label
- Busulfan
- description
- The Pharmacogenomics add-on requires 2X 5ml blood EDTA for further DNA analyses. Note this is an add-on study to NCT 01949129, THE ALL SCTped FORUM study. Please refer to the main study for further details.
- interventionNames
- Genetic: Pharmacogenomics
- Other: Busulfan plasma level measurements
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available