Last updated on August 2019

Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL

Brief description of study

The trial proposed to evaluate the efficacy and safety of an inotuzumab ozogamicin followed by an age-adapted intermediate intensive consolidation therapy and maintenance treatment in patients with acute lymphoblastic leukemia older than 56 years

Detailed Study Description

Despite recent advances especially in younger patients, the prognosis of elderly patients with ALL remains dismal with a 5-year survival rate of around 20%, even after intensive chemotherapy.

Inotuzumab ozogamicin (PF-05208773; CMC-544) is an antibody-targeted intravenous (IV) chemotherapy agent composed of an anti-CD22 antibody linked to calicheamicin, a potent cytotoxic antitumor antibiotic.

After a prephase treatment, induction therapy will be based on inotuzumab ozogamicin and intrathecal therapy only. After a maximum of three cycles, patients will receive an age adapted intermediate dose consolidation chemotherapy based on the backbone of the German Multicenter Study Group for adult ALL (GMALL). This will be followed by a conventional maintenance therapy. All patients will be followed for cytological response, minimal residual disease and safety parameters.

Clinical Study Identifier: NCT03460522

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Jena, Germany
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