Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING Phase 3

Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)

NCT05183035 · View on ClinicalTrials.gov ↗

Study Summary

A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, or in 2nd relapse.

Conditions Studied

Interventions

  • DRUG Venetoclax
  • DRUG Fludarabine
  • DRUG Azacitidine
  • DRUG Gemtuzumab Ozogamicin
  • DRUG Cytarabine

Study Locations (20)

Florida

  • Golisano Children's Hospital of Southwest Florida — Fort Myers
  • University of Florida Health Shands Children's Hospital — Gainesville
  • Nemours Children's Specialty Care Jacksonville — Jacksonville
  • Nemours Children's Hospital - Orlando — Orlando
  • Saint Joseph's Hospital - Tampa — Tampa

California

  • MemorialCare Miller Children's and Women's Hospital Long Beach — Long Beach
  • Children's Hospital of Orange County Main Campus - Orange — Orange
  • Benioff Children's Hospital - Mission Bay — San Francisco

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago
  • Comer Children's Hospital — Chicago

Arizona

  • Phoenix Children's Hospital — Phoenix

Arkansas

  • Arkansas Children's Hospital — Little Rock

Colorado

  • Children's Hospital Colorado — Aurora

Connecticut

  • Yale University — New Haven

Delaware

  • Nemours Alfred I. Dupont Hospital for Children — Wilmington

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2022-10-01
Est. Completion 2031-04
Phase Phase 3

Sponsor

PedAL BCU

35 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05183035

The ClinicalTrials.gov registry entry for NCT05183035 describes a study currently listed as recruiting. It is categorized as Phase 3, 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 98 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is PedAL BCU, which has 35 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 Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions — of which Venetoclax 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: NCT05183035 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, California, Illinois. 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 NCT05183035 about?

NCT05183035 is a clinical study titled "Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)". A study to evaluate if the randomized addition of venetoclax to a chemotherapy backbone (fludarabine/cytarabine/gemtuzumab ozogamicin \[GO\]) improves survival of children/adolescents/young adults with acute myeloid leukemia (AML) in 1st relapse who are unable to receive additional anthracyclines, o...

What is the current status of trial NCT05183035?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 98 participants. The study started on 2022-10-01. Estimated completion is 2031-04.

What conditions does trial NCT05183035 study?

This clinical trial studies the following conditions: Acute Myeloid 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 NCT05183035?

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

Who is sponsoring clinical trial NCT05183035?

This trial is sponsored by PedAL BCU, which has 35 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05183035 being conducted?

This trial has 20 study locations across Arizona, Arkansas, California, Colorado, Connecticut. 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