Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT04049539 · ClinicalTrials.gov registry record · Phase 1
Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction
A Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, sponsored by Ohio State University Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 2
- Study locations
NCT04049539 is a Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells that is actively recruiting participants, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 28 participants, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT04049539, a Phase 1 study of Refractory Acute Myeloid Leukemia and Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, is actively recruiting participants, sponsored by Ohio State University Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and daunorubicin contained in a liposome. Drugs used in chemotherapy, such as cytarabine and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cytarabine and daunorubicin given together in liposomes may have fewer side effects and work better than cytarabine and daunorubicin given alone in patients with acute myeloid leukemia.
Conditions Studied
Interventions
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Study Locations (2)
California
- UC Davis Comprehensive Cancer Center - Sacramento
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2021-01-29 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04049539
The ClinicalTrials.gov registry entry for NCT04049539 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 47-participant average among 63 other Refractory Acute Myeloid Leukemia trials with a reported enrollment target (40% lower). The listed sponsor is Ohio State University Comprehensive Cancer Center, which has 341 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Refractory Acute Myeloid Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Liposome-encapsulated Daunorubicin-Cytarabine is the first listed.
NCT04049539 reports 2 study locations spanning 2 distinct geographic areas - top geographies include California, Ohio.
Frequently Asked Questions
What is clinical trial NCT04049539 about?
NCT04049539 is a clinical study titled "Vyxeos for Re-induction Treatment of Acute Myeloid Leukemia Patients With Persistent Disease After Induction". This phase II trial studies the side effects and how well Vyxeos works in treating patients with intermediate and high-risk acute myeloid leukemia who have failed an initial cycle of standard cytarabine and daunorubicin chemotherapy. Vyxeos is a combination of both chemotherapy drugs cytarabine and ...
What is the current status of trial NCT04049539?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2021-01-29. Estimated completion is 2025-12-31.
What conditions does trial NCT04049539 study?
This clinical trial studies the following conditions: Refractory Acute Myeloid Leukemia, Blasts More Than 5 Percent of Bone Marrow Nucleated Cells, Persistent Disease.
What interventions are being tested in trial NCT04049539?
The interventions under investigation include: Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT04049539?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04049539 being conducted?
This trial has 2 study locations across California, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Refractory 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.
-
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Ruxolitinib in Combination With Venetoclax With and Without Azacitidine in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
-
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
RECRUITING · Phase 1
-
8-Chloroadenosine in Combination With Venetoclax for the Treatment of Patients With Relapsed/Refractory Acute Myeloid Leukemia
RECRUITING · Phase 1
Explore more on PlainTrial
Refractory Acute Myeloid Leukemia
All registered trials for this condition
Blasts More Than 5 Percent of Bone Marrow Nucleated Cells
All registered trials for this condition
California
All trials with a study site in California
Recruiting now
Find trials open to new participants near you
Rankings
Top sponsors, conditions, and phases
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.