Trial Profile

A PROSPECTIVE, RANDOMIZED, OPEN-LABEL PHASE 2 STUDY TO EVALUATE THE SUPERIORITY OF INOTUZUMAB OZOGAMICIN MONOTHERAPY VERSUS ALLR3 FOR INDUCTION TREATMENT OF CHILDHOOD HIGH RISK FIRST RELAPSE B-CELL PRECURSOR ACUTE LYMPHOBLASTIC LEUKAEMIA

Status: Recruiting

Phase of Trial: Phase II

Latest Information Update: 14 Sep 2025

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At a glance

Drugs Inotuzumab ozogamicin (Primary) ; Crisantaspase; Dexamethasone; Dexamethasone; Mitoxantrone; Pegaspargase; Vincristine
Indications Precursor B-cell lymphoblastic leukaemia-lymphoma
Focus Therapeutic Use
Sponsors Pfizer

18 Jun 2025 Planned End Date changed from 15 Oct 2036 to 4 Nov 2036.
18 Jun 2025 Planned primary completion date changed from 7 Dec 2033 to 31 Oct 2033.
23 Jan 2025 Planned End Date changed from 9 Jul 2031 to 15 Oct 2036.

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