OncRef

Clinical Trial: NCT03610438

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

Status:

ACTIVE NOT RECRUITING

Phase:

Phase 2

Lead Sponsor:Gruppo Italiano Malattie EMatologiche dell'Adulto
Information Provided By:Gruppo Italiano Malattie EMatologiche dell'Adulto
Last Update Posted:2026-07-16

Study Overview

Brief 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.

Official Title

A Phase IIA Study of Feasibility and Effectiveness of Inotuzumab Ozogamicin (IO) in Adult Patients With B-Cell Acute Lymphoblastic Leukemia With Positive Minimal Residual Disease Before Any Hematopoietic Stem Cell Transplantation

Conditions

Acute Lymphoid Leukemia

Intervention / Treatment

  • Drug: Inotuzumab Ozogamicin (IO)
  • Drug: Inotuzumab Ozogamicin (IO)

Other Study ID Numbers

  • ALL2418
  • 2018-003006-32
  • 2018

Start Date (Actual)

2019-10-30

Primary Completion Date (Actual)

2026-07-15

Study Completion Date (Estimated)

2026-10

Enrollment (Estimated)

76

Study Type

Interventional

Phase

Phase 2