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Phase I/II Study of the Combination of Inotuzumab Ozogamicin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

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Trial Profile

Phase I/II Study of the Combination of Inotuzumab Ozogamicin (CMC-544) With Low-Intensity Chemotherapy in Patients With Acute Lymphoblastic Leukemia (ALL)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 13 Jan 2026

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At a glance

  • Drugs Inotuzumab ozogamicin (Primary) ; Ursodeoxycholic acid (Primary) ; Blinatumomab; Cyclophosphamide; Cytarabine; Cytarabine; Dexamethasone; Dexamethasone; Doxorubicin; Mercaptopurine; Mesna; Methotrexate; Methotrexate; Methotrexate; Pegfilgrastim; Prednisone; Rituximab; Vincristine
  • Indications Precursor B-cell lymphoblastic leukaemia-lymphoma; Precursor cell lymphoblastic leukaemia-lymphoma
  • Focus Adverse reactions; Therapeutic Use

Most Recent Events

  • 18 Dec 2025 Planned End Date changed from 25 Dec 2025 to 25 Dec 2027.
  • 18 Dec 2025 Planned primary completion date changed from 25 Dec 2025 to 25 Dec 2027.
  • 10 Dec 2024 Protocol was also amended to increase the number of IT chemotherapy to 12, according to results presented at the 66th American Society of Hematology Annual Meeting and Exposition.

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