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NCT05183035 · ClinicalTrials.gov registry record · Phase 3
Venetoclax in Children With Relapsed Acute Myeloid Leukemia (AML)
A Phase 3 study of Acute Myeloid Leukemia, sponsored by PedAL BCU.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 98
- Enrollment target
- 20
- Study locations
NCT05183035 is a Phase 3 study of Acute Myeloid Leukemia that is actively recruiting participants, run by PedAL BCU. The registered enrollment target is 98 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% lower). The trial reports 20 study locations across 13 states.
The verdict
NCT05183035, a Phase 3 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by PedAL BCU.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 98 participants
- Enrollment target
- 20
- Study locations
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
| Field | Value |
|---|---|
| Enrollment Target | 98 participants |
| Start Date | 2022-10-01 |
| Est. Completion | 2031-04 |
| Phase | Phase 3 |
Interested in This Trial?
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, categorized as Phase 3. The registered enrollment target is 98 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% lower). The listed sponsor is PedAL BCU, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT05183035 reports 20 study locations spanning 13 distinct geographic areas - top geographies include Florida, California, Illinois.
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.
What interventions are being tested in trial NCT05183035?
The interventions under investigation include: Venetoclax (DRUG), Fludarabine (DRUG), Azacitidine (DRUG), Gemtuzumab Ozogamicin (DRUG), Cytarabine (DRUG).
Who is sponsoring clinical trial NCT05183035?
This trial is sponsored by PedAL BCU, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
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Related
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