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NCT06863259 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of B-cell Acute Lymphoblastic Leukemia, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
Phase 1
Development phase
28
Enrollment target
1
Study location

NCT06863259 is a Phase 1 study of B-cell Acute Lymphoblastic Leukemia that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 28 participants, below the 88-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (68% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06863259, a Phase 1 study of B-cell Acute Lymphoblastic Leukemia, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
1
Study location

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 Studied

B-cell Acute Lymphoblastic Leukemia

Interventions

  • DRUG Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone

Study Locations (1)

Ohio

  • Cincinnati Children's Hospital Medical Center - Cincinnati

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2025-05-21
Est. Completion 2029-01-01
Phase Phase 1

Sponsor

Children's Hospital Medical Center, Cincinnati

571 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06863259

The ClinicalTrials.gov registry entry for NCT06863259 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 88-participant average among 21 other B-cell Acute Lymphoblastic Leukemia trials with a reported enrollment target (68% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with B-cell Acute Lymphoblastic Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone is the first listed.

NCT06863259 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.

Frequently Asked Questions

What is clinical trial NCT06863259 about?

NCT06863259 is a clinical study titled "Study of Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone for Relapsed B-cell ALL". 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 ...

What is the current status of trial NCT06863259?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2025-05-21. Estimated completion is 2029-01-01.

What conditions does trial NCT06863259 study?

This clinical trial studies the following conditions: B-cell Acute Lymphoblastic Leukemia.

What interventions are being tested in trial NCT06863259?

The interventions under investigation include: Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (DRUG).

Who is sponsoring clinical trial NCT06863259?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06863259 being conducted?

This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.