Acute lymphoblastic leukemia (ALL)
Conditions
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion 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 T BM relapse, early/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 Are the trial subjects under 18? yes Number of subjects for this age range: 250 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - BCR-ABL/ t(9;22) positive ALL - Pregnancy or positive pregnancy test (urine sample positive for ß-HCG > 10 U/l) - Sexually active adolescents not willing to use highly effective contraceptive method (pearl index II - The whole protocol or essential parts are declined either by patient himself/herself or the respective legal guardian - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of CR rates after induction with ALL R3 with bortezomib versus without bortezomib in HR relapsed ALL patients;Secondary Objective: Improvement of EFS and OS rates Improvement of MRD reduction after induction with versus without bortezomib Toxicity of induction with versus without bortezomib Efficacy of consolidation elements to reduce MRD load until allo-HSCT;Primary end point(s): Primary endpoint of this trial is the rate of complete remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A);Timepoint(s) of evaluation of this end point: Primary endpoint will be evaluated at week 5 after induction. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints are improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD pre-HSCT, C2 and MRD rates during consolidation, toxicity of randomized arms.;Timepoint(s) of evaluation of this end point: End of study | — |
Countries
Australia, Austria, Belgium, Czechia, Czech Republic, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Portugal, Spain, Sweden, Switzerland
Contacts
Public ContactDept of Pediatric Oncology/Hematolo
Charité - Universitätsmedizin Berlin
Outcome results
None listed