Acute lymphoblastic leukemia (ALL) MedDRA version: 21.0 Level: LLT Classification code 10000845 Term: Acute lymphoblastic leukemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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 - 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 - Lodge an objection to the study participation by a minor patient, able to object - Any patient being dependent on the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Improvement of CR2 rates after induction with ALL R3 with bortezomib versus without bortezomib.;Secondary Objective: Improvement of EFS and OS rates Improvement of MRD reduction after induction with versus without bortezomib Improvement of MRD load prior to SCT Increasing the proportion of HR patients reaching SCT Prognostic relevance of MRD pre SCT Improvement of CR2 and/or MRD rates during consolidation Toxicity of induction with versus without bortezomib ;Primary end point(s): Randomized induction trial: Improvement of CR2 rates with standard chemotherapy + Bortezomib (Arm B) quantified by cytology 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): Improvement of three years EFS and OS, rate of patients reaching HSCT, MRD rates post induction and pre-HSCT, prognostic relevance of MRD and CR2 rates during consolidation, toxicity of randomized arms, ;Timepoint(s) of evaluation of this end point: - EFS, OS: three years after recruitment is completed - toxicity: together with the primary endpoint - MRD rates: 9 weeks after primary endpoint | — |
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