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Trial · NCT07476729

Registered outcomes21

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimarySR induction EFSFrom enrollment until 2 years after end of treatmenttimespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
PrimarySR-MRD good response consolidation DFSFrom enrollment until 2 years after end of treatmenttimespan of survival after achievnemt of eremission until endpoint relevant event (death in remission, relapse, secondary malignancy) or until end of follow up
PrimaryHR with CR2 consolidation DSFFrom enrollment until 2 years after end of treatmenttimespan of survival after achievnemt of eremission until endpoint relevant event (death in remission, relapse, secondary malignancy) or until end of follow up
PrimaryIsolated extramedullary manifestations: EFSFrom enrollment until 2 years after end of treatmenttimespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
PrimarySR induction: Pharmacokinetics Inotuzumabfrom enrollment until day 28cumulative area under the concentration-time curve (AUC)
SecondarySR induction: MRDDay 28 of inductionMRD negativity rate after induction quantified by flow- and/or PCR techniques
SecondarySR-MRD good response consolidation: OSFrom enrollment until 2 years after end of treatmenttimespan of survival until death or until end of follow up
SecondaryIsolated extramedullary manifestations: EFSFrom enrollment until 2 years after end of treatmenttimespan of survival until endpoint relevant event (nonresponse, death in remission, relapse, secondary malignancy) or until end of follow up
SecondarySR induction: allo-HSCTweek 14 to 20 after enrollmentProportion of patients requiring allo-HSCT
SecondarySR induction: OSfrom enrollment until 2 years after end of treatmenttimespan of survival until death or until end of follow up
SecondarySR induction: Toxicityfrom enrollement until end of protocol therapyToxicity (assessed by CTCAE grades and SAE reports)
SecondarySR induction: CD19 positive cellsweek 9 after enrollmentRate of patients with CD19 positive cells after SCB1 prior to Blinatumomab
SecondarySR-MRD good response consolidation: Toxicityfrom enrollment until end of treatment (week 132)Toxicity (quantified by CTCAE grades and SAE reports)
SecondaryIsolated extramedullary manifestations: OSfrom enrollment until 2 years after end of treatmenttimespan of survival until death or until end of follow up
SecondaryIsolated extramedullary manifestations: DFS by MRDfrom enrollment until 2 years after end of treatmenttimespan of survival after achievnemt of eremission until endpoint relevant event (death in remission, relapse, secondary malignancy) or until end of follow up by MD after induction (cut-off 10-4)
SecondaryHR with CR2 consolidation: OSfrom enrollment until 2 years after end of treatmenttimespan of survival until death or until end of follow up
SecondaryHR with CR2 consolidation: Toxicityfrom enrollment until end of treatment (day 100 post HSCT)Toxicity (assessed by CTCAE grades and SAE reports)
SecondaryHR with CR2 consolidation: MRDweek 13 after enrollmentMRD negativity rates before allo-HSCT quantified by flow- and/or PCR techniques
SecondaryHR with CR2 consolidation: allo-HSCTweek 14 after enrollmentallo-HSCT rates
SecondaryInotuzumab PKfrom enrollment until end of induction (day 28), before and 1 hour after start of inotuzumab infusionMaximum and through concentrations of inotuzumab

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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