Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06824168 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission
A Phase 2 study of Acute Myeloid Leukemia and Leukemia, sponsored by Daiichi Sankyo.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 20
- Study locations
NCT06824168: Recruiting Phase 2 study of Acute Myeloid Leukemia and Leukemia, sponsored by Daiichi Sankyo.
NCT06824168 is a Phase 2 study of Acute Myeloid Leukemia and Leukemia that is actively recruiting participants, run by Daiichi Sankyo. The registered enrollment target is 130 participants, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06824168, a Phase 2 study of Acute Myeloid Leukemia and Leukemia, is actively recruiting participants, sponsored by Daiichi Sankyo.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 20
- Study locations
Study Summary
This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not received allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Primary Outcome
TEAEs are defined as AEs with start or worsening date during the on-treatment period (from the first dose date of trial treatment to 30 days after the last dose date of trial treatment).
Conditions Studied
Interventions
- DRUG Quizartinib High Dose
- DRUG Quizartinib Low Dose
Study Locations (20)
Other
- Royal Adelaide Hospital - Adelaide
- Austin Health - Australia
- St. Vincent's Hospital Melbourne - Darlinghurst
- The Alfred Hospital - Melbourne
- Royal Perth Hospital - Perth
- Gold Coast University Hospital - Southport
- Westmead Hospital - Sydney
- Hospital Erasto Gaertner - Liga Paranaense de Combate ao Cancer - Curitiba
- Cetus Hospital Dia Oncologia - Minas Gerai
- Hospital de Clínicas de Porto Alegre - Porto Alegre
- Irmandade da Santa Casa de Misericórdia de Porto Alegre Centro Multidisciplinar de Pesquisa - Porto Alegre
New York
- Roswell Park Cancer Institute - Buffalo
- Weill Cornell - New York
- Westchester Medical College - Valhalla
- Clinical Research Allicance - Westbury
Texas
- The Methodist Hospital Research Institute - Houston
- The University of Texas MD Anderson Cancer Center - Houston
Maryland
- John Hopkins School of Medicine - Baltimore
Massachusetts
- Umass Memorial Health Care Systems - Worcester
Pennsylvania
- Spoknwrd Clinical Trials Inc. - Easton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2025-07-18 |
| Est. Completion | 2032-07-14 |
| Phase | Phase 2 |
What NCT06824168 shows while recruiting
NCT06824168 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, above the 115-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (13% higher).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Quizartinib High Dose is the first listed.
NCT06824168 names 20 study sites across 6 states, led by Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT06824168 about?
NCT06824168 is a clinical study titled "Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission". This clinical two-arm trial is designed to evaluate two doses of quizartinib as maintenance therapy after induction/consolidation in participants with FMS-like tyrosine kinase 3 (FLT3)-internal tandem duplication (ITD) (+) acute myeloid leukemia (AML) in first complete remission (CR) who have not re...
What is the current status of trial NCT06824168?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2025-07-18. Estimated completion is 2032-07-14.
What conditions does trial NCT06824168 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Leukemia.
What interventions are being tested in trial NCT06824168?
The interventions under investigation include: Quizartinib High Dose (DRUG), Quizartinib Low Dose (DRUG).
Who is sponsoring clinical trial NCT06824168?
This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06824168 being conducted?
This trial has 20 study locations across Maryland, Massachusetts, New York, Pennsylvania, Texas. 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 NCT06824168's enrollment target sits among peer trials
130 62nd of 306 higher than 244 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
-
Azacitidine or Decitabine With Venetoclax for Acute Myeloid Leukemia With Prior Hypomethylating Agent Failure
RECRUITING · Phase 2
-
Venetoclax + Azacitidine vs. Induction Chemotherapy in AML
RECRUITING · Phase 2
-
A Multi-phase Study of ASTX030 (Azacitidine and Cedazuridine) in Myeloid Neoplasm Alone or in Combination With Venetoclax in AML (AZTOUND Study)
RECRUITING · Phase 2
-
A Study of Tagraxofusp in Combination With Venetoclax and Azacitidine in Adults With Untreated CD123+ Acute Myeloid Leukemia Who Cannot Undergo Intensive Chemotherapy
RECRUITING · Phase 2
-
Venetoclax, Cladribine, Low Dose Cytarabine, and Azacitidine in Treating Patients With Previously Untreated Acute Myeloid Leukemia
RECRUITING · Phase 2
-
Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)
RECRUITING · Phase 2
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
- NCT01492036 · 130 participants
Long-Term Follow-Up of Recipient of Gene Transfer Research
- NCT01631617 · 130 participants · Phase 2
Effects of Treatments on Atopic Dermatitis
- NCT02368041 · 130 participants
Utility of Thenar Near Infrared Spectroscopy (NIRS) in Pediatric Patients With Heart Failure
- NCT02604277 · 130 participants · NA
Suicidal Behavior in Patients Diagnosed With Bipolar Disorder
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