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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: Active Phase 1 study of Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, sponsored by National Cancer Institute (NCI).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. The maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) will be determined. Based on the toxicity observed, a derived variable, the occurrence of dose limiting toxicity, will be created. Will be correlated with MDM2 Inhibitor KRT-232 (KRT-232) (MDM2 inhibitor AMG-232 \[AMG-232\]) and decitabine exposure. Toxicities will be tabulated and reported according to d

Conditions Studied

Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia Recurrent Acute Myeloid Leukemia Secondary Acute Myeloid Leukemia

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

FieldValue
Enrollment Target 58 participants
Start Date 2018-02-08
Est. Completion 2026-06-30
Phase Phase 1
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03041688 still lists

NCT03041688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (50% lower).

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 lists 13 locations in 6 states (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.

Learn More About Clinical Trials

Similar trials for 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.

Where NCT03041688's enrollment target sits among peer trials

58 128th of 306 higher than 178 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03041688, the US trial registry maintained by the National Library of Medicine. NCT03041688 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.