Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting Phase 3 study of Acute Myeloid Leukemia, sponsored by PedAL BCU.
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. According to ClinicalTrials.gov, the official US trial registry.
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 |
What NCT05183035 shows while recruiting
NCT05183035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (16% lower).
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 names 20 study sites across 13 states, led by 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.
Learn More About Clinical Trials
Similar trials for Acute Myeloid Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05183035's enrollment target sits among peer trials
98 86th of 306 higher than 221 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Acute Myeloid Leukemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Study to Compare Standard Chemotherapy to Therapy With CPX-351 and/or Gilteritinib for Patients With Newly Diagnosed AML With or Without FLT3 Mutations
RECRUITING · Phase 3
-
Mismatched Related Donor Versus Matched Unrelated Donor Stem Cell Transplantation for Children, Adolescents, and Young Adults With Acute Leukemia or Myelodysplastic Syndrome
ACTIVE NOT RECRUITING · Phase 3
-
Haploidentical Allogeneic Peripheral Blood Transplantation: Examining Checkpoint Immune Regulators' Expression
ACTIVE NOT RECRUITING · Phase 3
-
Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia
ACTIVE NOT RECRUITING · Phase 3
-
Galinpepimut-S Versus Investigator's Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
ACTIVE NOT RECRUITING · Phase 3
-
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
ACTIVE NOT RECRUITING · Phase 3
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02926729 · 98 participants · NA
Real-Time Assessment Of Breast Cancer Lumpectomy Specimen Margins With Nonlinear Microscopy
- NCT03382977 · 98 participants · Phase 1
Study to Evaluate Safety, Tolerability, and Optimal Dose of Candidate GBM Vaccine VBI-1901 in Recurrent GBM Subjects
- NCT04577014 · 98 participants · Phase 1
Retifanlimab (Anti-PD-1 Antibody) With Gemcitabine and Docetaxel in Patients With Advanced Soft Tissue Sarcoma
- NCT04817618 · 98 participants · Phase 3
Study of Efficacy and Safety of Iptacopan in Patients With C3 Glomerulopathy.
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI