Improving treatment for high-risk childhood relapsed leukemia
International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group
This study is testing a new treatment plan that combines a drug called bortezomib with standard therapies to see if it can help children and teens with high-risk relapsed leukemia do better and live longer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Charite University, Berlin, Germany Academic / other |
| Drugs / interventions | doxorubicin |
| Locations | 15 sites (Clayton, Victoria and 14 other locations) |
| Trial ID | NCT03590171 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance outcomes for children and adolescents with high-risk first relapse of acute lymphoblastic leukemia (ALL) by optimizing treatment strategies and integrating new agents like bortezomib. The study focuses on patients classified as high risk based on specific criteria, who typically have poor responses to standard therapies. By combining bortezomib with conventional treatments, researchers hope to improve survival rates and reduce the need for allogeneic hematopoietic stem cell transplantation. The trial is conducted internationally, involving multiple centers to gather a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates include children under 18 years with a confirmed diagnosis of first relapsed precursor B-cell or T-cell ALL who meet high-risk criteria.
Not a fit: Patients with BCR-ABL positive ALL or those who have relapsed after allogeneic stem cell transplantation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve survival rates for children with high-risk relapsed ALL.
How similar studies have performed: Other studies have shown promise with similar approaches, particularly the use of bortezomib in combination with conventional therapies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL * Children less than 18 years of age at date of inclusion into the study * Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early isolated/combined extramedullary relapse) * Patient enrolled in a participating centre * Written informed consent * Start of treatment falling into the study period * No participation in other clinical trials 30 day prior to study enrolment that interfere with this protocol, except trials for primary ALL Exclusion Criteria: * Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL * Pregnancy or positive pregnancy test (urine sample positive for β-humane choriongonadotropin (HCG) \> 10 U/l) * Sexually active adolescents not willing to use highly effective contraceptive method (pearl index \<1) until 12 months after end of anti-leukemic therapy * Breast feeding * Relapse post allogeneic stem-cell transplantation * Neuropathy \> II° * The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian * Objection to the study participation by a minor patient, able to object * Any patient being dependent on the investigator * No consent is given for saving and propagation of pseudonymized 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) * Subjects unwilling or unable to comply with the study procedures * Subjects who are legally detained in an official institute
Where this trial is running
Clayton, Victoria and 14 other locations
- Australian & New Zealand Childhood Hematology & Oncology Group — Clayton, Victoria, Australia (Recruiting)
- St. Anna Kinderkrebsforschung, CCRI — Vienna, Austria (Recruiting)
- Hòpital Universitaire des Enfants Reine Fabiola — Brussels, Belgium (Recruiting)
- University Hospital Motol — Prague, Czechia (Recruiting)
- Copenhagen University Hospital (Rigshospitalet) — Copenhagen, Denmark (Not_yet_recruiting)
- Turku University Central Hospital — Turku, Finland (Recruiting)
- CHU Nice — Nice, France (Recruiting)
- Tel Aviv Sourasky Medical Centre — Tel Aviv, Israel (Recruiting)
- Ospedale Pediatrico Bambino Gesù — Roma, Italy (Recruiting)
- Prinses Máxima Centrum, Lundlaan — Utrecht, Netherlands (Recruiting)
- Oslo University Hospital — Oslo, Norway (Not_yet_recruiting)
- Dpt. SCT and Hematology/Oncology University Wroclaw — Wroclaw, Poland (Recruiting)
- Instituto Português de Oncologia de Lisboa — Lisbon, Portugal (Not_yet_recruiting)
- University Hospital Stockholm — Stockholm, Sweden (Not_yet_recruiting)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Arend von Stackelberg, MD — Charite University, Berlin, Germany
- Study coordinator: Arend von Stackelberg, MD
- Email: arend.stackelberg@charite.de
- Phone: +49(0)30-450666
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.