Spots Global Cancer Trial Database for Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL
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Trial Identification
Brief Title: Inotuzumab Ozogamicin and Conventional Chemotherapy In Patients Aged 56 Years and Older With ALL
Official Title: Open Label Phase II Study to Evaluate the Efficacy and Safety of Inotuzumab Ozogamicin for Induction Followed by Chemotherapy Consolidation and Maintenance Therapy In Patients Aged 56 Years and Older With Acute Lymphoblastic Leukemia (ALL)
Study ID: NCT03460522
Conditions
Interventions
Study Description
Brief Summary: The trial proposed to evaluate the efficacy and safety of an inotuzumab ozogamicin followed by maintenance treatment in patients with acute lymphoblastic leukemia older than 56 years
Detailed 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 three cycles of inotuzumab ozogamicin and intrathecal therapy only. This will be followed by a conventional maintenance therapy. All patients will be followed for cytological response, minimal residual disease and safety parameters.
Keywords
Eligibility
Minimum Age: 56 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Klinikum Augsburg, Augsburg, , Germany
Universität Bonn, Bonn, , Germany
Klinikum Chemnitz gGmbH, Chemnitz, , Germany
Uniklinik Dresden, Dresden, , Germany
University Hospital DĂźsseldorf, DĂźsseldorf, , Germany
Universität Erlangen, Erlangen, , Germany
Univeristätsklinikum Essen, Essen, , Germany
University Hospital of Frankfurt, Frankfurt, , Germany
Universitätsklinikum Freiburg, Freiburg, , Germany
Universitätsklinikum Heidelberg, Heidelberg, , Germany
Uniklinikum, Jena, , Germany
University of Muenster, MĂźnster, , Germany
Klinikum NĂźrnberg Nord, NĂźrnberg, , Germany
Robert - Bosch - Krankenhaus, Stuttgart, , Germany
Contact Details
Name: Matthias Stelljes, MD
Affiliation: Universität Mßnster
Role: PRINCIPAL_INVESTIGATOR
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