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Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

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Trial Profile

Phase II Study of Pedi-cRIB: Mini-Hyper-CVD With Condensed Rituximab, Inotuzumab Ozogamicin and Blinatumomab (cRIB) for Relapsed Therapy for Pediatric With B-Cell Lineage Acute Lymphocytic Leukemia

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 28 Jan 2025

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At a glance

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

    • Most Recent Events

    • 10 Dec 2024 Results (n=14) reporting a chemotherapy minimized InO/Blina based treatment approach for frontline therapy in older pts with Ph-ve B-cell ALL presented at the 66th American Society of Hematology Annual Meeting and Exposition.
    • 10 Dec 2024 Trial design presented at the 66th American Society of Hematology Annual Meeting and Exposition.
    • 12 Dec 2023 Protocol was amended from patient 50 such that InO was given in fractionated doses with a maximum cumulative dose of 2.7mg/m2 (0.6 mg/m2 on D2 of C1, 0.3 mg/m2 on D8 of C1, then 0.3 mg/m2 on D2 and D8 of C2-4). Ursodeoxycholic acid was given to all patients. Four cycles of blina 28µg/day replaced C5-8 of mHCVD + InO, according to Results presented at the 65th American Society of Hematology Annual Meeting and Exposition

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