drugset
drugset / Trial / NCT03610438

Feasibility and Effectiveness of Inotuzumab Ozogamicin in B-Cell Acute Lymphoblastic Leukemia

NCT03610438 ↗

Phase 2 Active not recruiting 76 enrolled GIMEMA Foundation
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a multi-center, phase 2A exploratory study of feasibility and effectiveness of Inotuzumab Ozagomicin in adult patients with Acute Lymphoid Leukemia (ALL) with positive minimal residual disease before any hematopoietic stem cell transplantation. The study is divided in two cohorts; cohort 1 will enroll 38 Ph+ patients, cohort 2 will enroll 38 Ph- patients, as defined with statistical analysis. The two cohorts will have the same treatment, with the exception of short term and long term maintenance.

Timeline

Start
2019-10-30
Primary completion
2026-07-15
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Inotuzumab Ozogamicin Monoclonal antibody — —

Indications

acute lymphoblastic leukemia