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NCT04802161 · ClinicalTrials.gov registry record · Phase 2
Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 11
- Study locations
NCT04802161: Active Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, sponsored by National Cancer Institute (NCI).
NCT04802161 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower). The trial reports 11 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04802161, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndrome, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 11
- Study locations
Study Summary
This phase II trial studies the effect of adding pomalidomide to usual chemotherapy treatment (daunorubicin and cytarabine liposome) in treating patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes. Pomalidomide may stop the growth of blood vessels, stimulate the immune system, and kill cancer cells. Chemotherapy drugs, such as daunorubicin and cytarabine liposome, 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. Adding pomalidomide to chemotherapy treatment with daunorubicin and cytarabine liposome may be effective in improving some treatment outcomes in patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration and Biopsy
- DRUG Pomalidomide
- DRUG Liposome-encapsulated Daunorubicin-Cytarabine
Study Locations (11)
Ohio
- University of Cincinnati Cancer Center-UC Medical Center - Cincinnati
- Ohio State University Comprehensive Cancer Center - Columbus
- University of Cincinnati Cancer Center-West Chester - West Chester
Kansas
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Westwood Cancer Center - Westwood
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
- Wake Forest University Health Sciences - Winston-Salem
Georgia
- Emory University Hospital/Winship Cancer Institute - Atlanta
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
New York
- NYP/Weill Cornell Medical Center - New York
Virginia
- University of Virginia Cancer Center - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2022-08-24 |
| Est. Completion | 2026-04-25 |
| Phase | Phase 2 |
What the registry record for NCT04802161 still lists
NCT04802161 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (57% lower).
The record links to 6 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 4 interventions - of which Biospecimen Collection is the first listed.
NCT04802161 lists 11 locations in 7 states (Ohio, Kansas, North Carolina).
Frequently Asked Questions
What is clinical trial NCT04802161 about?
NCT04802161 is a clinical study titled "Comparing the Addition of an Anti-Cancer Drug, Pomalidomide, to the Usual Chemotherapy Treatment (Daunorubicin and Cytarabine Liposome) in Newly Diagnosed Acute Myeloid Leukemia With Myelodysplastic Syndrome-Related Changes". This phase II trial studies the effect of adding pomalidomide to usual chemotherapy treatment (daunorubicin and cytarabine liposome) in treating patients with newly diagnosed acute leukemia with myelodysplastic syndrome-related changes. Pomalidomide may stop the growth of blood vessels, stimulate th...
What is the current status of trial NCT04802161?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2022-08-24. Estimated completion is 2026-04-25.
What conditions does trial NCT04802161 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, Myeloproliferative Neoplasm, Acute Myeloid Leukemia Post Cytotoxic Therapy.
What interventions are being tested in trial NCT04802161?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration and Biopsy (PROCEDURE), Pomalidomide (DRUG), Liposome-encapsulated Daunorubicin-Cytarabine (DRUG).
Who is sponsoring clinical trial NCT04802161?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04802161 being conducted?
This trial has 11 study locations across Georgia, Kansas, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT04802161's enrollment target sits among peer trials
50 143rd of 306 higher than 154 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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