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New CML pill shows promise in Head-to-Head trial against standard treatments

NCT ID NCT04971226

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This study tests a new daily pill, asciminib, against several standard drugs for people newly diagnosed with a type of leukemia called CML. About 405 adults will be randomly assigned to receive either asciminib or a standard tyrosine kinase inhibitor (TKI). The main goal is to see if asciminib leads to a deeper reduction in cancer cells (major molecular response) by 48 weeks.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

405 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Jan 2031

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.

Inclusion Criteria for treatment period: Participants eligible for inclusion in this study must meet all of the following criteria: * Male or female patients ≥ 18 years of age. * Participants with CML-CP within 3 months of diagnosis. * Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of Philadelphia chromosome Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020): * \< 15% blasts in peripheral blood and bone marrow, * \< 30% blasts plus promyelocytes in peripheral blood and bone marrow, * \< 20% basophils in the peripheral blood, * Platelet count ≥ 100 x 10\^9/L (≥ 100,000/mm\^3), * No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. * Adequate end organ function as defined by: * Total bilirubin \< 3 x ULN; patients with Gilbert's syndrome may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN * Creatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula, * Serum lipase ≤ 1.5 x ULN. For serum lipase \> ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis \- Participants must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization: * Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl\* ≥ 90 mL/min) * Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl\* ≥ 90 mL/min) * Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl\* ≥ 90 mL/min) * For patients with mild to moderate renal impairment (CrCl\* ≥ 30 mL/min and \<90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization. * \*CrCl as calculated using Cockcroft-Gault formula * Ability to provide written informed consent prior to any study related screening procedures being performed. * Evidence of typical BCR-ABL1 transcript \[e14a2 and/or e13a2\] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification. Exclusion Criteria for Treatment period: * Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤2 weeks is allowed, but no other treatment with other tyrosine kinase inhibitors prior to randomization is permitted. * Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required). * Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one 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) * QTc ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc. * 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 * 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). Please refer to Section 6.3.1 * History of significant congenital or acquired bleeding disorder unrelated to cancer. * Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery. * 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 * History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis. * History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease. * Known hypersensitivity to the study treatment Other protocol-defined Inclusion/exclusion criteria will apply. Inclusion Criteria for optional TFR period: Participants meeting the following additional criteria are not eligible to enter the TRI Period: * Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests and other study procedures * A minimum of 5 years of study treatment up to maximum of 6 years of study treatment (i.e. participants are eligible to enter TFR any time between year 5 and year 6 of their study treatment * Sustained MR 4.0 (BCR::ABL1 IS ≤0.01%) or better, assessed by central laboratory for at least 2 years (equivalent to 104 weeks) which includes MR 4.5 (BCR::ABL1 IS ≤0.0032%) for at least 1 year (equivalent to 52 weeks) immediately prior to entry into the TFR Period, with the 5 last consecutive RQ-PCR (every 12 weeks) assessments at/or below MR 4.5. Entry into TFR Period should be no later than 12 weeks from the last MR 4.5 RQ-PCR assessment * Separate signed informed consent must be obtained prior to participation in the TFR Period Exclusion Criteria for optional TFR period: * Participants meeting the following additional criterion are not eligible for the inclusion in the optional TFR Period: * Participants in the treatment re-initiation (TRI) Period cannot re-enter TFR for a second TFR attempt Exclusion Criteria for Treatment Re-initiation (TRI) Period Participants meeting the following additional criterion are not eligible to enter the TRI Period: * In case of a pregnancy during the TFR Period, the pregnant woman must be discontinued upon loss of MMR (\>0.1% BCR::ABL1 IS at a single assessment) and cannot enter the TRI Period * Impaired cardiac function or cardiac repolarization abnormality * 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

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Conditions

The condition(s) this trial relates to.

chronic myelogenous leukemia, BCR-ABL1 positive Leukemia, Myelogenous, Chronic, BCR-ABL Positive Philadelphia Chromosome

As listed by the trial registrant

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

Chronic myeloid leukemia (CML) philadelphia chromosome positive

Contacts and locations

Locations

  • Avera Cancer

    Sioux Falls, South Dakota, 57105, United States

  • Chattanooga Onc And Hem Assoc PC

    Chattanooga, Tennessee, 37404, United States

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901, United States

  • Florida Cancer Specialists Pan

    Tallahassee, Florida, 32308, United States

  • Novartis Investigative Site

    Kingswood, New South Wales, 2747, Australia

  • Novartis Investigative Site

    Port Macquarie, New South Wales, 2444, Australia

  • Novartis Investigative Site

    Adelaide, South Australia, 5000, Australia

  • Novartis Investigative Site

    Southport, 4215, Australia

  • Novartis Investigative Site

    Linz, Upper Austria, 4010, Austria

  • Novartis Investigative Site

    Leuven, Vlaams Brabant, 3000, Belgium

  • Novartis Investigative Site

    Brussels, 1000, Belgium

  • Novartis Investigative Site

    Varna, 9010, Bulgaria

  • Novartis Investigative Site

    Calgary, Alberta, T2N 5G2, Canada

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 1C3, Canada

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6, Canada

  • Novartis Investigative Site

    Toronto, Ontario, M5G 2M9, Canada

  • Novartis Investigative Site

    Guangzhou, Guangdong, 510515, China

  • Novartis Investigative Site

    Shenzhen, Guangdong, 518037, China

  • Novartis Investigative Site

    Zhengzhou, Henan, 450008, China

  • Novartis Investigative Site

    Wuhan, Hubei, 430022, China

  • Novartis Investigative Site

    Nanjing, Jiangsu, 210000, China

  • Novartis Investigative Site

    Suzhou, Jiangsu, 215004, China

  • Novartis Investigative Site

    Xian, Shanxi, 710068, China

  • Novartis Investigative Site

    Chengdu, Sichuan, 610041, China

  • Novartis Investigative Site

    Hangzhou, Zhejiang, 310003, China

  • Novartis Investigative Site

    Wenzhou, Zhejiang, 325000, China

  • Novartis Investigative Site

    Beijing, 100044, China

  • Novartis Investigative Site

    Beijing, 100730, China

  • Novartis Investigative Site

    Lanzhou, 730000, China

  • Novartis Investigative Site

    Tianjin, 300020, China

  • Novartis Investigative Site

    Ostrava, Poruba, 708 52, Czechia

  • Novartis Investigative Site

    Brno, 625 00, Czechia

  • Novartis Investigative Site

    Hradec Králové, 500 05, Czechia

  • Novartis Investigative Site

    Aarhus N, 8200, Denmark

  • Novartis Investigative Site

    Copenhagen, 2100, Denmark

  • Novartis Investigative Site

    Helsinki, 00290, Finland

  • Novartis Investigative Site

    Bordeaux, 33076, France

  • Novartis Investigative Site

    Lyon, 69373, France

  • Novartis Investigative Site

    Nantes, 44093, France

  • Novartis Investigative Site

    Paris, 75475, France

  • Novartis Investigative Site

    Mannheim, Baden-Wurttemberg, 68305, Germany

  • Novartis Investigative Site

    Frankfurt am Main, Hesse, 60590, Germany

  • Novartis Investigative Site

    Jena, Thuringia, 07740, Germany

  • Novartis Investigative Site

    Aachen, 52074, Germany

  • Novartis Investigative Site

    Berlin, 13353, Germany

  • Novartis Investigative Site

    Lübeck, 23538, Germany

  • Novartis Investigative Site

    Debrecen, Hajdu Bihar Megye, 4032, Hungary

  • Novartis Investigative Site

    Kaposvár, 7400, Hungary

  • Novartis Investigative Site

    Kecskemét, 6001, Hungary

  • Novartis Investigative Site

    Delhi, 110085, India

  • Novartis Investigative Site

    Petah Tikva, 4941492, Israel

  • Novartis Investigative Site

    Ramat Gan, 5265601, Israel

  • Novartis Investigative Site

    Tel Aviv, 6423906, Israel

  • Novartis Investigative Site

    Bologna, BO, 40138, Italy

  • Novartis Investigative Site

    Milan, MI, 20122, Italy

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123, Italy

  • Novartis Investigative Site

    Roma, RM, 00161, Italy

  • Novartis Investigative Site

    Verona, VR, 37134, Italy

  • Novartis Investigative Site

    Nagoya, Aichi-ken, 4538511, Japan

  • Novartis Investigative Site

    Toyoake, Aichi-ken, 4701192, Japan

  • Novartis Investigative Site

    Sapporo, Hokkaido, 0608648, Japan

  • Novartis Investigative Site

    Kobe, Hyōgo, 6500047, Japan

  • Novartis Investigative Site

    Kurashiki, Okayama-ken, 7108602, Japan

  • Novartis Investigative Site

    Sakai, Osaka, 5900197, Japan

  • Novartis Investigative Site

    Suita, Osaka, 5650871, Japan

  • Novartis Investigative Site

    Shimotsuke, Tochigi, 3290498, Japan

  • Novartis Investigative Site

    Chūō, Yamanashi, 4093898, Japan

  • Novartis Investigative Site

    Akita, 0108543, Japan

  • Novartis Investigative Site

    Fukuoka, 8128582, Japan

  • Novartis Investigative Site

    Fukushima, 9601295, Japan

  • Novartis Investigative Site

    Osaka, 5458586, Japan

  • Novartis Investigative Site

    Yamagata, 9909585, Japan

  • Novartis Investigative Site

    Kuantan, Pahang, 25100, Malaysia

  • Novartis Investigative Site

    George Town, Pulau Pinang, 10450, Malaysia

  • Novartis Investigative Site

    Subang Jaya, Selangor, 47500, Malaysia

  • Novartis Investigative Site

    Kuala Selangor, 68000, Malaysia

  • Novartis Investigative Site

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Novartis Investigative Site

    Bergen, NO-5021, Norway

  • Novartis Investigative Site

    Oslo, 0372, Norway

  • Novartis Investigative Site

    Porto, 4200-072, Portugal

  • Novartis Investigative Site

    Vila Nova de Gaia, 4434-502, Portugal

  • Novartis Investigative Site

    Singapore, 119074, Singapore

  • Novartis Investigative Site

    Singapore, 169608, Singapore

  • Novartis Investigative Site

    Košice, 041 90, Slovakia

  • Novartis Investigative Site

    Uijeongbu-si, Gyeonggi-do, 11759, South Korea

  • Novartis Investigative Site

    Seoul, 03080, South Korea

  • Novartis Investigative Site

    Seoul, 06351, South Korea

  • Novartis Investigative Site

    Seoul, 06591, South Korea

  • Novartis Investigative Site

    Granada, Andalusia, 18014, Spain

  • Novartis Investigative Site

    El Palmar, Murcia, 30120, Spain

  • Novartis Investigative Site

    Pamplona, Navarre, 31008, Spain

  • Novartis Investigative Site

    Barcelona, 08036, Spain

  • Novartis Investigative Site

    Madrid, 28046, Spain

  • Novartis Investigative Site

    Gothenburg, 413 45, Sweden

  • Novartis Investigative Site

    Lund, 221 85, Sweden

  • Novartis Investigative Site

    Stockholm, 141 86, Sweden

  • Novartis Investigative Site

    Bellinzona, 6850, Switzerland

  • Novartis Investigative Site

    Taichung, 40447, Taiwan

  • Novartis Investigative Site

    London, W12 0HS, United Kingdom

  • Novartis Investigative Site

    Nottingham, NG5 1PB, United Kingdom

  • Novartis Investigative Site

    Oxford, OX3 7LE, United Kingdom

  • Oregon Health Sciences University

    Portland, Oregon, 97239, United States

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218, United States

  • Texas Oncology

    Amarillo, Texas, 79124, United States

  • Texas Oncology

    Dallas, Texas, 75251, United States

  • Texas Oncology-Baylor USO

    Dallas, Texas, 75246, United States

  • Uni of Massachusetts Medical Center

    Worcester, Massachusetts, 01655, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157, United States

  • Williamette Cancer Center

    Eugene, Oregon, 97401, United States