At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Bortezomib (drug)
- How long the study runs
- Study runs about 123 months (dates as stated)
- About the drug or intervention
- Bortezomib — drug: Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol.
- Patient visit burden
- Not specified by the sponsor
In plain English
This international study looks at treatment for children and young people under 18 whose acute lymphoblastic leukaemia (ALL), a cancer of the white blood cells, has come back after previous treatment and is classed as high risk. It is sponsored by Charite University, Berlin, Germany. Further details about the study's aims and treatments are not stated — ask the trial team.
Who can take part
- Children under 18 years old when they join the study
- A confirmed diagnosis of first relapsed B-cell or T-cell acute lymphoblastic leukaemia (ALL), meaning the cancer has come back after earlier treatment
- The relapse meets the study's high-risk criteria, which includes relapse in the bone marrow or certain early relapses outside the bone marrow
- Being treated at a hospital taking part in the study
- Written informed consent (agreement) from the patient and/or parent or guardian
- Starting treatment during the study period
- No participation in other clinical trials in the 30 days before joining, unless they are trials for the original ALL treatment
Who may not be able to
- A type of leukaemia called BCR-ABL or t(9;22) positive ALL
- Pregnancy, a positive pregnancy test, or breastfeeding
- Sexually active teenagers not willing to use highly effective contraception until 12 months after leukaemia treatment ends
- Relapse after a donor stem-cell transplant
- Nerve damage (neuropathy) worse than grade II
- The patient, parent, or guardian declines the study treatment or does not agree to the storage and sharing of anonymised medical data for the study
- A child who is able to object and does object to taking part
- Being dependent on (in a close relationship with) the researcher
- Another serious health problem that would make the study treatment unsafe, in the researcher's view
- Being unwilling or unable to follow the study procedures
- Being legally detained in an official institution
What taking part involves
- • Not stated — ask the trial team
Time commitment: Not stated — ask the trial team about hospital visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- Up to 17 Years
- Who
- All
- Number of participants
- 250
- Started
- 2017-09-01
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for acute lymphoblastic leukemia (all)
- • Phase2 - 250 participants
- • The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents
Who can take part?
- • Ages Up to 17 Years
- • Diagnosed with acute lymphoblastic leukemia (all)
Where?
- • Manchester - Royal Manchester Children's Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The main goal of this study is to improve the outcome of children and adolescents with acute lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies within a large international trial and the integration of new agents.
More detail
Though survival of children with acute lymphoblastic leukemia (ALL) has considerably improved over the past few decades, relapsed ALL remains a leading cause of mortality in children with cancer. Risk has been defined by the International (I) Berlin, Frankfurt, Münster (BFM) Study Group (SG) based on duration of first remission, immunophenotype of malignant clone, and site of relapse. Patients classified as high risk (HR) by these criteria have poor response rates to standard induction therapy, high rates of subsequent relapse and require an allogeneic hematopoetic stem cell transplantation (allo-HSCT) for consolidation of 2nd remission. Over the last decade members of the I-BFM-SG have investigated the use of different combinations of conventional cytotoxic agents. Even with allo-HSCT, none of these approaches have improved outcome above 40%. Therefore, for HR patients there is a need to investigate the curative potential of new agents combined with systemic therapy. The proteasome inhibitor bortezomib has shown synergistic activity with acceptable toxicity when combined with corticosteroids, anthracyclines and alkylating agents in adult patients with cancer as well as with dexamethasone, doxorubicin, vincristine and polyethylene glycol (PEG) asparaginase in children with refractory or relapsed ALL. In the I-BFM-SG International Study for Treatment of High Risk Childhood Relapsed ALL (IntReALL) HR 2010 study, the potential of Bortezomib combined with a modified ALL relapse protocol 3 (R3) backbone as induction regimen for HR patients to improve complete 2nd remission (CR2) rates will be investigated in a randomized phase II design. Induction is followed by conventional intensive consolidation. After termination of the trial patients may be subjected to an investigational window, before all of them receive allo-HSCT.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Up to 17 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓Patient enrolled in a participating centre
- ✓Written agreement to take part
Who cannot take part
- ✗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...
- ✗Breast feeding
- ✗Relapse post allogeneic stem-cell transplantation
See the full criteria
Where Is This Study? (1 UK site)
Royal Manchester Children's Hospital
Manchester M13 9WL, United Kingdom
How to Get in Touch
Arend von Stackelberg, MD
Sponsor contactCONTACT