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NCT04128748 · ClinicalTrials.gov registry record · Phase 1
Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome
A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
- 1
- Study location
NCT04128748: Recruiting Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by M.D. Anderson Cancer Center.
NCT04128748 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is actively recruiting participants, run by M.D. Anderson Cancer Center. The registered enrollment target is 52 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04128748, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is actively recruiting participants, sponsored by M.D. Anderson Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works 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. Quizartinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. The goal of this study is to learn if the combination of CPX-351 and quizartinib can help to control acute myeloid leukemia and myelodysplastic syndrome.
Primary Outcome
Will follow standard reporting guidelines for adverse events, and summarize safety data by category, severity and frequency.
Conditions Studied
Interventions
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
- DRUG Quizartinib
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2020-05-27 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
What NCT04128748 shows while recruiting
NCT04128748 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 52 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (55% lower).
The record links to 7 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Liposome-encapsulated Daunorubicin-Cytarabine is the first listed.
NCT04128748 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT04128748 about?
NCT04128748 is a clinical study titled "Liposomal Cytarabine and Daunorubicin (CPX-351) and Quizartinib for the Treatment of Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome". This phase I/II trial studies the side effects and best dose of CPX-351 in combination with quizartinib for the treatment of acute myeloid leukemia and high risk myelodysplastic syndrome. CPX-351, composed of chemotherapy drugs daunorubicin and cytarabine, works in different ways to stop the growth ...
What is the current status of trial NCT04128748?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2020-05-27. Estimated completion is 2027-12-31.
What conditions does trial NCT04128748 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Recurrent Myelodysplastic Syndrome, Refractory Myelodysplastic Syndrome.
What interventions are being tested in trial NCT04128748?
The interventions under investigation include: Liposome-encapsulated Daunorubicin-Cytarabine (DRUG), Quizartinib (DRUG).
Who is sponsoring clinical trial NCT04128748?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04128748 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04128748's enrollment target sits among peer trials
52 138th of 306 higher than 167 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.
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