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RECRUITING Phase 1

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

NCT06863259 · View on ClinicalTrials.gov ↗

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.

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

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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 715 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06863259 reports 1 study location spanning 1 distinct geographic area — top geographies include Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06863259?

The interventions under investigation include: Inotuzumab Ozogamicin, Venetoclax, and Dexamethasone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06863259?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 715 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial