The IntReALL BCP 2020 study aims to review recent developments and findings regarding chemoimmunotherapy with inotuzumab and immunotherapy with blinatumomab and to increase the use of promising new immunotherapeutic drugs as replacements for toxic SOC chemotherapy elements.
The IntReALL BCP 2020 study has the potential to improve CR and EFS rates for all SR and HR groups, as well as for patients with IEM recurrence, by replacing toxic chemotherapy with targeted, less toxic immunotherapy strategies, and could establish these new approaches as SOC for children with relapsed BCP ALL in the future.
Confirmed diagnosis of 1st relapsed B-cell precursor ALL
Patients ≥ 1 year and less than 18 years of age at diagnosis of primary ALL and less than 21 years of age at date of inclusion into the study
Patient enrolled in a participating center
Written informed consent (IC)
Known hypersensitivity to the active substances or excipients of the IMP's or the SOC drugs, except to PEG-asparaginase which can be replaced by Erwinase
Left ventricular ejection fraction (LVEF) < 50% or fractional shortening < 25%, and/or current or prior treatment for cardiomyopathy and/or history of clinically significant arrhythmias
Pregnancy or positive pregnancy test in female patients (urine sample positive for β-HCG > 10 U/l) at screening or within 7 days prior to the initiation of study treatment
Sexually active adolescents and adults not willing to use highly effective contraceptive method (pearl index <1) until 12 months after end of anti-leukemic therapy
Parallel
Inotuzumab ozogamicin (INO)
DrugAntibody Drug Conjugate (Inotuzumab)
Blinatumomab
DrugBispecific t-cell enganger BiTE
SR induction EFS
timespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
SR-MRD good response consolidation DFS
timespan of survival after achievnemt of eremission until endpoint relevant event (death in remission, relapse, secondary malignancy) or until end of follow up
HR with CR2 consolidation DSF
timespan of survival after achievnemt of eremission until endpoint relevant event (death in remission, relapse, secondary malignancy) or until end of follow up
Isolated extramedullary manifestations: EFS
timespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
SR induction: MRD
MRD negativity rate after induction quantified by flow- and/or PCR techniques
SR-MRD good response consolidation: OS
timespan of survival until death or until end of follow up
Isolated extramedullary manifestations: EFS
timespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
SR induction: allo-HSCT
Proportion of patients requiring allo-HSCT
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