BridgeMD
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 BFM Study Group – IntReALL HR 2010
EU CTIS ID: 2024-513070-21-00
What this study is testing
Improvement of CR2 rates after induction with ALL R3 with bortezomib versus without bortezomib in HR relapsed ALL patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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 T 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
You likely can't join if
- BCR-ABL/ t(9;22) positive ALL
- 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
- Pregnancy or positive pregnancy test (urine sample positive for β-HCG > 10 U/l)
See the full eligibility 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 T 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
- BCR-ABL/ t(9;22) positive ALL
- 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
- Pregnancy or positive pregnancy test (urine sample positive for β-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
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.