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Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients

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Trial Profile

Treatment Optimization in Adult Patients With Newly Diagnosed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma by Individualised, Targeted and Intensified Treatment - a Phase IV-trial With a Phase III-part to Evaluate Safety and Efficacy of Nelarabine in T-ALL Patients

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 09 Apr 2025

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At a glance

  • Drugs Nelarabine (Primary) ; Nelarabine (Primary) ; Cyclophosphamide; Cytarabine; Dasatinib; Daunorubicin; Dexamethasone; Doxorubicin; Etoposide; Fludarabine; Idarubicin; Imatinib; Mercaptopurine; Methotrexate; Pegaspargase; Prednisolone; Rituximab; Vincristine; Vindesine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma; Precursor T-cell lymphoblastic leukaemia-lymphoma
  • Focus Therapeutic Use

Most Recent Events

  • 06 Jan 2025 Status changed from active, no longer recruiting to completed.
  • 10 Dec 2024 According to Results presented at the 66th American Society of Hematology Annual Meeting and Exposition, After an amendment a TKI change was recommended if the MRD value was above >10-3 BCR::ABL1/ABL1 after C1.9 patients were switched to Dasatinib according to the recommendations after the amendment.
  • 12 Dec 2023 Primary endpoint (time from start of induction to start of C1) has not been met, according to Results presented at the 65th American So.ciety of Hematology Annual Meeting and Exposition

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