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NCT05886049 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene
A Phase 1 study of Acute Myeloid Leukemia With KMT2A Rearrangement and Acute Myeloid Leukemia With NPM1 Mutation, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 28
- Enrollment target
- 20
- Study locations
NCT05886049 is a Phase 1 study of Acute Myeloid Leukemia With KMT2A Rearrangement and Acute Myeloid Leukemia With NPM1 Mutation that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 28 participants. The trial reports 20 study locations across 8 states.
The verdict
NCT05886049, a Phase 1 study of Acute Myeloid Leukemia With KMT2A Rearrangement and Acute Myeloid Leukemia With NPM1 Mutation, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 28 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5613 blocks signals passed from one molecule to another inside cancer cells that are needed for cancer cell survival. Drugs used in chemotherapy, such as daunorubicin and cytarabine, 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 SNDX-5613 to the standard chemotherapy treatment may be able to shrink or stabilize the cancer for longer than the standard chemotherapy treatment alone.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Cytarabine
- DRUG Daunorubicin
Study Locations (20)
Florida
- UM Sylvester Comprehensive Cancer Center at Aventura - Aventura
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Kansas
- University of Kansas Clinical Research Center - Fairway
- University of Kansas Cancer Center - Kansas City
- University of Kansas Hospital-Indian Creek Campus - Overland Park
- University of Kansas Hospital-Westwood Cancer Center - Westwood
North Carolina
- UNC Lineberger Comprehensive Cancer Center - Chapel Hill
- Carolinas Medical Center/Levine Cancer Institute - Charlotte
- Wake Forest University Health Sciences - Winston-Salem
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
California
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Illinois
- University of Chicago Comprehensive Cancer Center - Chicago
Maryland
- University of Maryland/Greenebaum Cancer Center - Baltimore
Oklahoma
- University of Oklahoma Health Sciences Center - Oklahoma City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2024-06-20 |
| Est. Completion | 2027-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05886049
The ClinicalTrials.gov registry entry for NCT05886049 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. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Acute Myeloid Leukemia With KMT2A Rearrangement appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT05886049 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Florida, Kansas, North Carolina.
Frequently Asked Questions
What is clinical trial NCT05886049 about?
NCT05886049 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene". This phase Ib trial tests the safety, side effects, and best dose of SNDX-5613 when given in combination with the standard chemotherapy treatment (daunorubicin and cytarabine) in treating patients with newly diagnosed acute myeloid leukemia that has changes in the NPM1 gene or MLL/KMT2A gene. SNDX-5...
What is the current status of trial NCT05886049?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-06-20. Estimated completion is 2027-12-31.
What conditions does trial NCT05886049 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia With KMT2A Rearrangement, Acute Myeloid Leukemia With NPM1 Mutation.
What interventions are being tested in trial NCT05886049?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Cytarabine (DRUG), Daunorubicin (DRUG).
Who is sponsoring clinical trial NCT05886049?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05886049 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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