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

NCT06863259 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-02-18

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone

Subjects will receive a course of inotuzumab ozogamicin administered by central venous catheter over 60 minutes on days 1, 8, and 15. Venetoclax (by mouth or NG) and dexamethasone (by mouth, NG, or IV) are given daily per assigned dose level. Venetoclax and dexamethasone are started 2 days prior to inotuzumab to limit risk of tumor lysis syndrome with a two-day venetoclax ramp up in cycle 1. On days 1 and 8, venetoclax administration should be scheduled for 4 hours after the beginning of inotuzumab ozogamicin administration. If the patient is not able to ingest venetoclax at the scheduled time, it may still be given later in the day, but efforts should be made to administer the venetoclax within 2 hours of the scheduled time whenever possible.

Sponsors & Collaborators

  • Children's Hospital Medical Center, Cincinnati

    lead OTHER

Principal Investigators

  • Jeremy Rubinstein, MD, PhD · Children's Hospital Medical Center, Cincinnati

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
39 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-21
Primary Completion
2028-01-01
Completion
2029-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863259 on ClinicalTrials.gov