NCT03460522

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

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)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Nicola Goekbuget · Academic / Other
• Sex: All
• Age: 56 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Precursor Cell Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Inotuzumab ozogamicin	Patients will receive standard of care chemotherapy (only maintenance) after Inotuzumab Ozogamicin.

Timeline

• Start date: 2018-05-02
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2018-03-09
• Last updated: 2022-11-02

Locations

14 sites across 1 country: Germany