New drug cocktail takes aim at Hard-to-Treat leukemia

NCT ID NCT06001788

Recruiting now Disease control Sponsor: Kura Oncology, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage trial is testing a new drug called ziftomenib combined with standard chemotherapy or another targeted drug for people with relapsed or treatment-resistant acute myeloid leukemia (AML) that has specific genetic changes. The main goal is to see if these combinations are safe and tolerable. About 171 participants will receive different treatment combinations to find the best dose and check for side effects.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance

ziftomenib (a targeted drug) combined with chemotherapy (FLAG-IDA, low-dose cytarabine) or gilteritinib

What this could lead to

If successful, this could point toward a new combination treatment option for people with hard-to-treat AML who have specific genetic mutations.

What could go wrong

This is an early Phase 1 trial with only 171 participants, focused on safety. It is too soon to know if the combinations will work better than existing treatments, and side effects are unknown.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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Conditions

The condition(s) this trial relates to.

acute leukemia acute myeloid leukemia acute myeloid leukemia with mutated NPM1 acute myeloid leukemia, MLL gene rearrangement early-onset generalized dystonia hematopoietic and lymphoid cell neoplasm hematopoietic and lymphoid system neoplasm leukemia myeloid leukemia neoplasm Neoplasms by Histologic Type

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ACUTE LEUKEMIA ACUTE MYELOID LEUKEMIA AML AML WITH MUTATED NPM1 HEMATOLOGIC MALIGNANCY KMT2AR LEUKEMIA LEUKEMIA, MYELOID LEUKEMIA, MYELOID, ACUTE MLL REARRANGEMENT NEOPLASMS BY HISTOLOGIC TYPE NPM1 MUTATION

Contacts and locations

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Study contacts

Contact

Phone: •••-•••-•••• Email: •••••@•••••

Locations

Atrium Health Levine Cancer Center
RECRUITING

Charlotte, North Carolina, 60201, United States

Contact Email: •••••@•••••
Banner MD Anderson Cancer Center
RECRUITING

Gilbert, Arizona, 85234, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Beth Israel Deaconess Medical Center
RECRUITING

Boston, Massachusetts, 02215, United States
Colorado Blood Cancer Institute
RECRUITING

Denver, Colorado, 80218, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Emory Healthcare - The Emory Clinic
RECRUITING

Atlanta, Georgia, 30322, United States

Contact Email: •••••@•••••
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING

Roma, 00168, Italy

Contact Phone: •••-•••-•••• Email: •••••@•••••
Froedtert & Medical College Clinics
RECRUITING

Milwaukee, Wisconsin, 53226, United States
Georgia Cancer Center at Augusta University
RECRUITING

Augusta, Georgia, 30912, United States

Contact Email: •••••@•••••
Henry Ford Cancer Institute
RECRUITING

Detroit, Michigan, 48202, United States

Contact Email: •••••@•••••
Hospital Universitari Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain

Contact Phone: •••-•••-•••• Email: •••••@•••••
Hospital Universitari y Politecnic La Fe
RECRUITING

Valencia, 46026, Spain

Contact Phone: •••-•••-•••• Email: •••••@•••••
Hospital Universitario Central de Asturias
RECRUITING

Oviedo, 33011, Spain

Contact Phone: •••-•••-•••• Email: •••••@•••••
Hospital Universitario Virgen del Rocío
RECRUITING

Seville, 41013, Spain

Contact Phone: •••-•••-•••• Email: •••••@•••••
IRCCS Azienda Ospedaliero-Universitaria do Bologna - Policlinico di Sant'Orsola
RECRUITING

Bologna, 40138, Italy

Contact Phone: •••-•••-•••• Email: •••••@•••••
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING

Hackensack, New Jersey, 07601, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Karmanos Cancer Institute
RECRUITING

Detroit, Michigan, 48201, United States
Lehigh Valley Topper Cancer Institute
WITHDRAWN

Allentown, Pennsylvania, 18103, United States
Loyola University Medical Center
RECRUITING

Maywood, Illinois, 60153, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
MD Anderson Cancer Center
RECRUITING

Houston, Texas, 77030, United States

Contact Email: •••••@•••••
Memorial Sloan Kettering Cancer Center
RECRUITING

New York, New York, 10021, United States

Contact Phone: •••-•••-••••
Northwell Health, LLC PRIME
RECRUITING

Lake Success, New York, 11042, United States
OU Health Stephenson Cancer Center
RECRUITING

Oklahoma City, Oklahoma, 73104, United States

Contact Email: •••••@•••••
Ospedale Santa Maria delle Croci
RECRUITING

Ravenna, 48121, Italy

Contact Phone: •••-•••-•••• Email: •••••@•••••
Prisma Health
RECRUITING

Greenville, South Carolina, 29615, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••

Contact Phone: •••-•••-•••• Email: •••••@•••••
Robert H. Lurie Comprehensive Cancer Center of Northwestern University
RECRUITING

Chicago, Illinois, 60611, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Roswell Park Comprehensive Cancer Center
RECRUITING

Buffalo, New York, 14263, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Simmons Cancer Institute
WITHDRAWN

Springfield, Illinois, 62702, United States
Smilow Cancer Hospital at Yale New Haven
RECRUITING

New Haven, Connecticut, 06511, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Stony Brook Cancer Center
RECRUITING

Stony Brook, New York, 11794, United States

Contact Email: •••••@•••••
Texas Oncology - Baylor Charles A. Sammons Cancer Center
RECRUITING

Dallas, Texas, 75246, United States

Contact Email: •••••@•••••
The University of Kansas Cancer Center
RECRUITING

Kansas City, Kansas, 66160, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
UC Irvine Health Chao Family Comprehensive Cancer Center
RECRUITING

Orange, California, 92868, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
UCLA Health - Bowyer Oncology Center
RECRUITING

Los Angeles, California, 90095, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
UH Seidman Cancer Center
RECRUITING

Cleveland, Ohio, 44106, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
USC Norris Comprehensive Cancer Center
RECRUITING

Los Angeles, California, 90089, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
University of California San Francisco
RECRUITING

San Francisco, California, 94115, United States
University of Iowa Hospitals & Clinics
RECRUITING

Iowa City, Iowa, 52242, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
University of Nebraska Medical Center
RECRUITING

Omaha, Nebraska, 68198, United States
University of Vermont
RECRUITING

Burlington, Vermont, 05401, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
University of Virginia Comprehensive Cancer Center
RECRUITING

Charlottesville, Virginia, 22903, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
University of Washington
RECRUITING

Seattle, Washington, 98109, United States
Vanderbilt University Medical Center
RECRUITING

Nashville, Tennessee, 37232, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Washington University School of Medicine
RECRUITING

St Louis, Missouri, 63110, United States
Weill Cornell Medical College-NY Presbyterian Hospital
RECRUITING

New York, New York, 10065, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••
Wilmot Cancer Institute, University of Rochester
RECRUITING

Rochester, New York, 14642, United States

Contact Phone: •••-•••-•••• Email: •••••@•••••