RecruitingPhase 1NCT06863259

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

A Phase 1 Study With a Pilot Expansion Phase of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (IoVeX) for Relapsed B-cell Acute Lymphoblastic Leukemia (B-ALL)

Sponsor

Children's Hospital Medical Center, Cincinnati

Enrollment

28 participants

Start Date

May 21, 2025

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 1 YearMax Age: 39 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — inotuzumab ozogamicin, venetoclax, and dexamethasone — in people with relapsed or treatment-resistant B-cell acute lymphoblastic leukemia (B-ALL), a type of blood cancer. **You may be eligible if...** - You have been diagnosed with relapsed B-ALL with cancer cells in more than 5% of your bone marrow - At least 20% of your leukemia cells carry a marker called CD22 on their surface - You meet one of the additional criteria set by the study (such as being in first or second relapse, or having treatment-resistant disease) **You may NOT be eligible if...** - Your leukemia cells do not have CD22 on their surface - You are in a later line of relapse without meeting specific criteria - You have had prior treatment with certain drugs that would make you ineligible - Your overall health does not meet the study's requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInotuzumab 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.