Safety and Tolerability of Ziftomenib Combinations in Patients With Relapsed/Refractory Acute Myeloid Leukemia
Condition(s) studied
Investigational drug(s) / intervention(s)
Ziftomenib: Oral administration
Fludarabine: Intravenous infusion
Idarubicin: Intravenous infusion
Cytarabine: Intravenous Infusion
Gilteritinib: Oral administration
Granulocyte colony-stimulating factor: Subcutaneous injection
Study summary
The safety, tolerability, and antileukemic response of ziftomenib in combination with standard of care treatments for patients with relapsed/refractory acute myeloid leukemia will be examined with the following agents: FLAG-IDA, low-dose cytarabine, and gilteritinib.
Eligibility
Primary outcome measure(s)
- Rate of dose limiting toxicities (DLTs) per dose level — During the first 28 days of ziftomenib in combination with SOC treatment (1 cycle)
Assessed by the NCI-CTCAE v5.0 - Descriptive statistics of adverse events — First dose of ziftomenib up to and including 28 days after last dose of ziftomenib, or if the patient is lost to follow-up, whichever comes first
Assessed by the NCI-CTCAE v5.0
Trial sites (45)
| Facility | City | Region | Status |
|---|---|---|---|
| Banner MD Anderson Cancer Center | Gilbert | Arizona | Recruiting |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| UCLA Health - Bowyer Oncology Center | Los Angeles | California | Recruiting |
| UC Irvine Health Chao Family Comprehensive Cancer Center | Orange | California | Recruiting |
| University of California San Francisco | San Francisco | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Smilow Cancer Hospital at Yale New Haven | New Haven | Connecticut | Recruiting |
| Emory Healthcare - The Emory Clinic | Atlanta | Georgia | Recruiting |
| Georgia Cancer Center at Augusta University | Augusta | Georgia | Recruiting |
| Robert H. Lurie Comprehensive Cancer Center of Northwestern University | Chicago | Illinois | Recruiting |
| Loyola University Medical Center | Maywood | Illinois | Recruiting |
| Simmons Cancer Institute | Springfield | Illinois | Withdrawn |
| University of Iowa Hospitals & Clinics | Iowa City | Iowa | Recruiting |
| The University of Kansas Cancer Center | Kansas City | Kansas | Recruiting |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | Recruiting |
| Karmanos Cancer Institute | Detroit | Michigan | Recruiting |
| Henry Ford Cancer Institute | Detroit | Michigan | Recruiting |
| Washington University School of Medicine | St Louis | Missouri | Recruiting |
| University of Nebraska Medical Center | Omaha | Nebraska | Recruiting |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | Recruiting |
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | Recruiting |
| Northwell Health, LLC PRIME | Lake Success | New York | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Weill Cornell Medical College-NY Presbyterian Hospital | New York | New York | Recruiting |
| Wilmot Cancer Institute, University of Rochester | Rochester | New York | Recruiting |
| Stony Brook Cancer Center | Stony Brook | New York | Recruiting |
| Atrium Health Levine Cancer Center | Charlotte | North Carolina | Recruiting |
| UH Seidman Cancer Center | Cleveland | Ohio | Recruiting |
| OU Health Stephenson Cancer Center | Oklahoma City | Oklahoma | Recruiting |
| Lehigh Valley Topper Cancer Institute | Allentown | Pennsylvania | Withdrawn |
| Prisma Health | Greenville | South Carolina | Recruiting |
| Vanderbilt University Medical Center | Nashville | Tennessee | Recruiting |
| Texas Oncology - Baylor Charles A. Sammons Cancer Center | Dallas | Texas | Recruiting |
| MD Anderson Cancer Center | Houston | Texas | Recruiting |
| University of Vermont | Burlington | Vermont | Recruiting |
| University of Virginia Comprehensive Cancer Center | Charlottesville | Virginia | Recruiting |
| University of Washington | Seattle | Washington | Recruiting |
| Froedtert & Medical College Clinics | Milwaukee | Wisconsin | Recruiting |
| IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola | Bologna | Italy | Recruiting |
| Ospedale Santa Maria delle Croci | Ravenna | Italy | Recruiting |
+ 5 more sites — see the full list on the official registry below.
More Kura Oncology, Inc. trials in Italy
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06001788 on ClinicalTrials.gov ↗ ← All trials in Italy