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NCT03041688 · ClinicalTrials.gov registry record · Phase 1
Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 13
- Study locations
NCT03041688 is a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 58 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (50% lower). The trial reports 13 study locations across 6 states.
The verdict
NCT03041688, a Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 13
- Study locations
Study Summary
This phase Ib trial studies the side effects and best dose of navtemadlin when given together with decitabine and venetoclax in treating patients with acute myeloid leukemia that has come back after a period of improvement (recurrent), does not respond to treatment (refractory), or is newly diagnosed. Navtemadlin may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Chemotherapy drugs, such as decitabine, 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. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Giving navtemadlin, decitabine, and venetoclax together may work better than decitabine alone in treating patients with acute myeloid leukemia.
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Bone Marrow Aspiration
- PROCEDURE Bone Marrow Biopsy
- DRUG Decitabine
- DRUG Navtemadlin
Study Locations (13)
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- Keck Medical Center of USC Pasadena - Pasadena
- University of California Davis Comprehensive Cancer Center - Sacramento
Massachusetts
- Massachusetts General Hospital Cancer Center - Boston
- Brigham and Women's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
- Dana-Farber Cancer Institute - Boston
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Maryland
- Johns Hopkins University/Sidney Kimmel Cancer Center - Baltimore
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Virginia
- VCU Massey Comprehensive Cancer Center - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2018-02-08 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03041688
The ClinicalTrials.gov registry entry for NCT03041688 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 58 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (50% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT03041688 reports 13 study locations spanning 6 distinct geographic areas - top geographies include California, Massachusetts, Kentucky.
Frequently Asked Questions
What is clinical trial NCT03041688 about?
NCT03041688 is a clinical study titled "Testing a New Chemotherapy Drug, KRT-232 (AMG-232) in Combination With Decitabine and Venetoclax in Patients With Acute Myeloid Leukemia". This phase Ib trial studies the side effects and best dose of navtemadlin when given together with decitabine and venetoclax in treating patients with acute myeloid leukemia that has come back after a period of improvement (recurrent), does not respond to treatment (refractory), or is newly diagnose...
What is the current status of trial NCT03041688?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 2018-02-08. Estimated completion is 2026-06-30.
What conditions does trial NCT03041688 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Recurrent Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia.
What interventions are being tested in trial NCT03041688?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Bone Marrow Aspiration (PROCEDURE), Bone Marrow Biopsy (PROCEDURE), Decitabine (DRUG), Navtemadlin (DRUG).
Who is sponsoring clinical trial NCT03041688?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03041688 being conducted?
This trial has 13 study locations across California, Kentucky, Maryland, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.