drugset / Trial / NCT06863259

Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL

NCT06863259

Phase 1 Recruiting 28 enrolled Children's Hospital Medical Center, Cincinnati
NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if the combination of drugs Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) are safe to treat relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL) in pediatric and adult patients. It will also learn if these drugs are well tolerated. The main questions it aims to answer are: Is the drug combination of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) safe when given to patients? What medical problems do patients taking IoVeX experience? Participants will: Receive this combination of drugs for 1 cycle which is 28 days at various timepoints. If participants tolerate cycle 1 they will be eligible to continue to cycle 2 which is also 28 days. Have checkups and tests at the beginning of the study and throughout the course of each cycle.

Timeline

Start
2025-05-21
Primary completion
2028-01-01
Completion
2029-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule Oral
Subject Inotuzumab Ozogamicin Monoclonal antibody Intravenous
Subject Venetoclax Small molecule Oral