Pfizer Inc ((PFE)) announced an update on their ongoing clinical study.
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Pfizer Inc. is conducting a Phase 2 clinical study titled 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. The study aims to assess the effectiveness and safety of Inotuzumab Ozogamicin (InO) compared to the ALLR3 regimen in children aged 1 to under 18 years with high-risk first relapse of B-cell precursor acute lymphoblastic leukemia (ALL).
The intervention being tested is Inotuzumab Ozogamicin, a CD22-targeted antibody drug conjugate, used as monotherapy. It is compared against the ALLR3 regimen, which includes a combination of chemotherapy drugs such as vincristine, mitoxantrone, dexamethasone, and PEG-asparaginase.
This interventional study is randomized with a parallel assignment model and no masking, focusing primarily on treatment. Participants are randomly allocated in a 2:1 ratio to receive either InO or the ALLR3 regimen.
The study began on May 17, 2023, and is currently recruiting. The primary completion date is set for July 17, 2025, which is also the last update submission date. These dates are crucial for tracking the progress and timeline of the study.
The outcome of this study could significantly impact Pfizer’s market position, potentially boosting investor confidence if InO proves superior. It may also influence the competitive landscape in pediatric oncology treatments, where effective relapse therapies are in demand.
The study is ongoing, and further details can be accessed on the ClinicalTrials portal.