Clinical trial · Observational
Studying Body Mass Index in Younger Patients Who Are Receiving Treatment for High-Risk Acute Lymphoblastic Leukemia
Impact of Obesity on the Pharmacokinetics of Anticancer Therapy in Children With High Risk Acute Lymphoblastic Leukemia (ALL)
- 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)
This clinical trial is studying body mass index in younger patients receiving prednisone/prednisolone, vincristine, daunorubicin, and pegaspargase for high-risk acute lymphoblastic leukemia. Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about the affect of body mass index on the way anticancer drugs work in the body. It may also help doctors predict how patients will respond to treatment
Conditions
Conditions (2)
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 |
| Untreated Childhood Acute Lymphoblastic Leukemia | Childhood Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Daunorubicin Hydrochloride | Drug | Daunorubicin | ALIAS |
| Pharmacological Study | Other | — | UNRESOLVED |
| Prednisolone | Drug | Prednisolone | ALIAS |
| Prednisone | Drug | Prednisone | ALIAS |
| Vincristine Sulfate | Drug | Vincristine | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Basic science (pharmacokinetics)
- description
- Patients receive anticancer therapy as prescribed by their treating clinicians. Patients receive prednisone/prednisolone orally twice on either day 1 or day 8. Patients also receive daunorubicin hydrochloride IV over 30 minutes and vincristine IV once on the same day.
- interventionNames
- Drug: Daunorubicin Hydrochloride
- Other: Pharmacological Study
- Drug: Prednisolone
- Drug: Prednisone
- Drug: Vincristine Sulfate
Primary outcomes (3)
- measure
- Pharmacokinetic parameters of prednisone/prednisolone
- timeFrame
- Pre-dose, 0.5, 1, 1.5, 2, 4, 6 to 8, 10 and 12 hours
- description
- Two multiple comparisons (normal weight versus obese and normal weight versus underweight groups) will be conducted with a priori planned contrasts using the Bonferroni adjustment method.
- measure
- Pharmacokinetic parameters of daunorubicin hydrochloride
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 10 Years
- Maximum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must be newly diagnosed with acute lymphoblastic leukemia and the intended induction treatment must contain prednisone/prednisolone, vincristine and daunorubicin in the doses and schedule as per the current COG AALL0232 protocol; prior registration onto a COG protocol is not required * Patients must be able to take either prednisone/prednisolone reliably by mouth on day 1 or 8 of induction (depending on sampling schedule chosen); patients who are being sampled on Induction day 8 and who have received intravenous corticosteroid therapy in the first week of induction must have received a minimum of six oral prednisone/prednisolone doses prior to the morning prednisone/prednisolone dose on induction day 8 Exclusion Criteria: * Serum transaminase concentrations \>= 5 X ULN for age * Total serum bilirubin (conjugated + unconjugated) \>= 1.5 mg/dl (\>= 26 micromol/L) * Serum creatinine \> 1.5 X ULN for age * With the exception of prednisone/prednisolone, receipt of medications or food known or with the potential to alter the pharmacokinetics of the drugs under study within 14 days of diagnosis and throughout the period of pharmacokinetic sampling; such agents include but are not limited to: grapefruit, tangelos or the juice of these fruits; St. Johns wort; anticonvulsants: carbamazepine, oxcarbazepine, phenytoin, phenobarbital, primidone; azole antifungal agents: ketoconazole, fluconazole, itraconazole, voriconazole; macrolide antibiotics: erythromycin, clarithromycin; isoniazid; rifampin; verapamil; and diltiazem * Presence of known malabsorption syndrome * Females with known pregnancy (pregnancy test must be negative to be eligible)
References
Publications (0)
Data not yet available