Treatment of Acute Lymphoblastic Leukemia in Children and Adolescents
A French Protocol for the Treatment of Acute Lymphoblastic Leukemia (ALL) in Children and Adolescents
PHASE3 · Assistance Publique - Hôpitaux de Paris · NCT02716233
This study is testing different doses and ways to give a medication called pegaspargase to see if it can improve treatment for children and teens with acute lymphoblastic leukemia.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1578 (estimated) |
| Ages | 12 Months to 18 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 28 sites (Amiens and 27 other locations) |
| Trial ID | NCT02716233 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the optimal use of L-asparaginase in treating acute lymphoblastic leukemia (ALL) in children and adolescents. It is a French multicentric cohort study that stratifies participants based on the type of ALL (B vs T lineage) and their anticipated risk. The study aims to evaluate the efficacy of different doses and administration methods of pegaspargase, a modified form of L-asparaginase, to improve treatment outcomes. By comparing these approaches, the trial seeks to enhance the therapeutic strategy for ALL in younger patients.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents diagnosed with B-lineage or T-lineage acute lymphoblastic leukemia.
Not a fit: Patients with L3 (Burkitt's leukemia), mixed phenotype acute leukemia, infant ALL (age ≤ 365 days), or Philadelphia chromosome-positive ALL may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for children and adolescents with acute lymphoblastic leukemia.
How similar studies have performed: Other studies have shown success with similar approaches in treating acute lymphoblastic leukemia, indicating that this methodology is promising.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ALL L1 or L2 * B-lineage or T- lineage ALL Exclusion Criteria: * L3 (Burkitt's leukemia) * Mixed Phenotype Acute Leukemia (WHO criteria). * Infant ALL (age ≤ 365 days) * Philadelphia (Ph)+/Breakpoint Cluster region (BCR)-Abelson (ABL) ALL
Where this trial is running
Amiens and 27 other locations
- CHU — Amiens, France (RECRUITING)
- CHU — Angers, France (RECRUITING)
- CHRU — Besançon, France (RECRUITING)
- CHU — Bordeaux, France (RECRUITING)
- CHU — Brest, France (RECRUITING)
- CHU — Caen, France (RECRUITING)
- CHU — Clermont-Ferrand, France (RECRUITING)
- CHU — Dijon, France (RECRUITING)
- CHU — Grenoble, France (RECRUITING)
- CHU — Lille, France (RECRUITING)
- CHU — Limoges, France (RECRUITING)
- Chu-Ihope — Lyon, France (RECRUITING)
- CHU — Marseille, France (RECRUITING)
- CHU — Montpellier, France (RECRUITING)
- CHU — Nancy, France (RECRUITING)
- CHU — Nantes, France (RECRUITING)
- CHU — Nice, France (RECRUITING)
- CHU Saint Louis — Paris, France (RECRUITING)
- CHU Armand Trousseau — Paris, France (RECRUITING)
- CHU Robert Debré — Paris, France (RECRUITING)
- CHU — Poitiers, France (RECRUITING)
- CHU — Reims, France (RECRUITING)
- CHU — Rennes, France (RECRUITING)
- CHU — Rouen, France (RECRUITING)
- CHU — Saint Etienne, France (RECRUITING)
- CHU — Strasbourg, France (RECRUITING)
- CHU — Toulouse, France (RECRUITING)
- CHu — Tours, France (RECRUITING)
Study contacts
- Study coordinator: André Baruchel, MD
- Email: andre.baruchel@aphp.fr
- Phone: +33 1 40 03 53 88
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.
Conditions: Acute Lymphoblastic Leukemia