New hope for leukemia patients: asciminib trial underway

NCT ID NCT05384587

Disease control Sponsor: Novartis Pharmaceuticals Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 trial tests asciminib, a daily oral drug, in 34 adults with chronic myeloid leukemia. Some participants have already tried one other treatment, while others are newly diagnosed. The study aims to see if asciminib can reduce cancer cells to very low levels. Doses may be increased over time based on response.

What this could mean

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

Active substance: asciminib (a targeted oral drug for leukemia)
What this could lead to: If successful, asciminib could offer a new treatment option for people with chronic myeloid leukemia who have not responded well to other therapies.
What could go wrong: This is a small, early-phase trial with only 34 participants, so results may not apply to everyone. The drug may cause side effects or fail to control the disease long-term.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

34 people

The number who actually took part.

Started

Nov 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Participants eligible for inclusion in this study must meet the following criteria: Criteria #1-5 are common to both patient cohorts (2L and 1L): 1. Signed informed consent must be obtained prior to participation in the study 2. CML-CP, no previous AP or BC 3. ≥ 18 years of age 4. ECOG performance status of 0, 1 or 2 5. Adequate end organ function within 14 days before the first dose of asciminib treatment. Patients with mild to moderate renal and hepatic impairment are eligible if: * Total bilirubin ≤ 3.0 x ULN without AST/ALT increase * Aspartate transaminase (AST) ≤ 5.0 x ULN * Alanine transaminase (ALT) ≤ 5.0 x ULN * Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN and ≤ 1.5 x ULN, value should be considered not clinically significant and not associated with risk factors for acute pancreatitis * Alkaline phosphatase ≤ 2.5 x ULN * Creatinine clearance ≥ 30 mL/min as calculated using Cockcroft- Gault formula Criteria #6 and 7 are specific to the 2L patient cohort. These are meant to be either/or. It is not required to have both criteria satisfied. 6. Warning or failure (according to 2020 ELN Recommendations; Hochhaus et al) to 1L TKI therapy at the time of screening a. Warning is defined as: i. Six months after the initiation of treatment: BCR::ABL1IS \>1-10% ii. Twelve months after the initiation of treatment: BCR::ABL1IS \>0.1-1% b. Treatment failure/resistance to 1L TKI is defined as: i. BCR::ABL1IS \>10% if 1L treatment duration between 6 and 12 months ii. BCR::ABL1IS \>1% if 1L treatment longer than 12 months treatment iii. Beyond 12 months after initiation of treatment: loss of MMR 7. Treatment intolerance to 1L TKI, 1. BCR::ABL1IS \> 0.1% at screening 2. Intolerance is defined as: i. Non-hematologic intolerance: Patients with grade 3 or 4 toxicity while on therapy, or with persistent grade 2 toxicity, unresponsive to optimal management, including dose adjustments (unless dose reduction is not considered in the best interest of the patient if response is already suboptimal) ii. Hematologic intolerance: Patients with grade 3 or 4 toxicity (absolute neutrophil count \[ANC\] or platelets) while on therapy that is recurrent after dose reduction to the lowest doses recommended by manufacturer Criteria #8 is specific to the 1L patient cohort 8. Patients with newly diagnosed CML-CP (treatment with a prior TKI (imatinib, or nilotinib, or dasatinib or bosutinib) for ≤ 4 weeks is allowed) Key Exclusion Criteria: 1. Previous treatment 1. With 2 or more ATP-binding site TKIs (for 2L patient cohort) 2. More than 4 weeks with 1-ATP-binding site TKIs (for 1L patient cohort) 2. Previous treatment with asciminib 3. Known presence of the T315I mutation at any time prior to study entry 4. Known second chronic phase of CML after previous progression to AP/BC 5. Previous treatment with a hematopoietic stem-cell transplantation 6. Patient planning to undergo allogeneic hematopoietic stem cell transplantation 7. Cardiac or cardiac repolarization abnormality, including any of the following: * History within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) * Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block) * QTcF at screening ≥450 msec (male patients), ≥450 msec (female patients) * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: * Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia * Concomitant medication(s) with a "Known risk of Torsades de Pointes" per www.crediblemeds.org that cannot be discontinued or replaced 7 days prior to starting study drug by safe alternative medication * Inability to determine the QTcF interval 8. History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis 9. Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer 10. Treatment with medications that meet one of the following criteria is not allowed and should be switched to an alternative at least one week prior to the start of treatment with study treatment: * Strong inducers of CYP3A for patients on the dose of 80 mg QD and 200mg QD * Strong inducers and inhibitors of CYP3A for patients on the dose of 200 mg BID 11. Pregnant or nursing (lactating) women 12. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception. Highly effective contraception for women should be maintained throughout the study and for at least 7 days after the last dose. 13. Sexually active males unwilling to use a condom during intercourse while taking study treatment and for 7 days after stopping study (only for patients treated with asciminib). 14. Severe and/or uncontrolled concurrent medical disease that in the opinion of the Investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection; uncontrolled arterial or pulmonary hypertension, uncontrolled clinically significant hyperlipidemia). 15. History of other active malignancy within 3 years prior to study entry with the exception of previous or concomitant basal cell skin cancer and previous carcinoma in situ treated curatively. 16. Known hypersensitivity to the study treatment.

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myeloid, Chronic-Phase

As listed by the trial registrant

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

Chronic myelogenous leukemia - chronic phase

Contacts and locations

Locations

Alaska Oncology and Hematology

Anchorage, Alaska, 99508, United States
Alta Bates Summit Medical Center

Oakland, California, 94609, United States
Augusta University Georgia

Augusta, Georgia, 30912, United States
Avera Cancer

Sioux Falls, South Dakota, 57105, United States
Baptist MD Anderson Cancer Center

Jacksonville, Florida, 32207, United States
Bon Secours Cancer Center

Greenville, South Carolina, 29607, United States
Care Access Research

Easton, Pennsylvania, 18045, United States
Care Access Research Clifton

Clifton, New Jersey, 07013, United States
City Of Hope Atlanta

Atlanta, Georgia, 30033, United States
City of Hope National Medical

Duarte, California, 91010, United States
City of Hope Phoenix

Scottsdale, Arizona, 85258, United States
Clinical Research Alliance

Lake Success, New York, 11042, United States
Community Cancer Trials of Utah

Ogden, Utah, 84405, United States
Ctr For Cancer And Blood Disorders

Fort Worth, Texas, 76104, United States
Dana Farber Cancer Center

Boston, Massachusetts, 02215, United States
Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States
Dean Health System

Madison, Wisconsin, 53717, United States
Duke University Medical Center

Durham, North Carolina, 27710, United States
Emory University School of Medicine Winship Cancer Institute

Atlanta, Georgia, 30308, United States
Florida Cancer Specialists

Fort Myers, Florida, 33901, United States
Florida Cancer Specialists East

Stuart, Florida, 34994, United States
Florida Cancer Specialists-North

St. Petersburg, Florida, 33705, United States
Franciscan Health Indianapolis

Indianapolis, Indiana, 42637, United States
Fred Hutch Cancer Research

Seattle, Washington, 98109, United States
Gabrail Cancer Center

Canton, Ohio, 44718, United States
Hackensack Meridian Health

Edison, New Jersey, 88837, United States
Hackensack University Medical Ctr

Hackensack, New Jersey, 07601, United States
Hematology Oncology Care

Cincinnati, Ohio, 45236, United States
Henry Ford Hospital

Detroit, Michigan, 48202-2689, United States
Holden Comp Can Cent Quad Cities U

Iowa City, Iowa, 52242, United States
Houston Methodist Hospital

Houston, Texas, 77030, United States
Huntsman Cancer Institute

Salt Lake City, Utah, 84112, United States
Investigative Clinicl Rsrch of Indi

Indianapolis, Indiana, 46260, United States
Jackson Onc Associates

Jackson, Mississippi, 39216, United States
James Cancer Hospital and Solove Research Institute Ohio State

Columbus, Ohio, 43210, United States
Louisiana State University

Shreveport, Louisiana, 71130, United States
Lundquist Inst BioMed at Harbor

Torrance, California, 90509-2910, United States
Manhattan Hematol Oncol Associates

New York, New York, 10016, United States
Mays Cancer Center

San Antonio, Texas, 78229, United States
Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States
Mt Sinai Medical Center

New York, New York, 10029-6574, United States
NYU Langone Long Island

Mineola, New York, 11501, United States
Nebraska Hematology Oncology P C

Lincoln, Nebraska, 68506, United States
New York Bld And Cancer Specialists

Port Jefferson, New York, 11776, United States
Northwest Georgia Oncology Center

Marietta, Georgia, 30060, United States
Northwest Medical Specialties

Tacoma, Washington, 98405, United States
Novant Health Heart Vas Inst

Charlotte, North Carolina, 28204, United States
Onco Inst of Hope and Innovation

Cerritos, California, 90703, United States
Oregon Health Sciences University

Portland, Oregon, 97239, United States
Rocky Mountain Cancer Centers

Boulder, Colorado, 80304, United States
Rutgers Cancer Institute of NJ

New Brunswick, New Jersey, 08901, United States
SUNY Stony Brook Medical Oncology

Stony Brook, New York, 11794-8174, United States
SUNY Upstate Medical Center

Syracuse, New York, 13210, United States
Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States
Siteman Cancer Center

St Louis, Missouri, 63110, United States
St Vincent Frontier Cancer Center

Billings, Montana, 59102, United States
Texas Oncology

Dallas, Texas, 75251, United States
Texas Oncology Northeast Texas

Tyler, Texas, 75702, United States
Texas Oncology P A

Austin, Texas, 78121, United States
Texas Oncology San Antonio

San Antonio, Texas, 78258, United States
The Stamford Hospital

Stamford, Connecticut, 06904, United States
Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States
UCLA

Los Angeles, California, 90095, United States
UCSF Fresno Internal Medicine

Fresno, California, 93701, United States
UNM

Albuquerque, New Mexico, 87102, United States
UPMC

Pittsburgh, Pennsylvania, 15213, United States
USO Arizona Oncology

Tucson, Arizona, 85711, United States
Univ of TX MD Anderson Cancer Cntr

Houston, Texas, 77030, United States
University Missouri Ellis Fischel Cancer Center

Columbia, Missouri, 65203, United States
University of Alabama at Birmingham

Birmingham, Alabama, 35233-0271, United States
University of Kentucky

Lexington, Kentucky, 40536, United States
University of North Carolina

Chapel Hill, North Carolina, 27514, United States
VA Puget Sound Health Care System

Seattle, Washington, 98108, United States
Virginia Cancer Institute

Richmond, Virginia, 23230, United States
Virginia Cancer Specialists

Gainesville, Virginia, 20155, United States
Virginia K Crosson Cancer Center

Fullerton, California, 92835, United States
Virginia Oncology Associates

Norfolk, Virginia, 23502, United States
Wake Forest Uni Health Sci

Winston-Salem, North Carolina, 27157, United States
Wichita Community Clcl Onco Program

Wichita, Kansas, 67214, United States
Yale University School Of Medicine

New Haven, Connecticut, 06520, United States

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