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Chronic Myelogenous Leukemia - Chronic PhasePhase 2ASC2ESCALATENCT05384587

Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia

A Phase 2 study testing asciminib in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Novartis Pharmaceuticals at 80 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
asciminib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
80 sitesUnited States
Study dates
11 Nov 2022to 17 Oct 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants eligible for inclusion in this study must meet the following criteria: Criteria #1-5 are common to both patient cohorts (2L and 1L):
  • Signed informed consent must be obtained prior to participation in the study
  • CML-CP, no previous AP or BC
  • ≥ 18 years of age
  • ECOG performance status of 0, 1 or 2
  • Adequate end organ function within 14 days before the first dose of asciminib treatment.
Show all 22Show fewer
  • 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.
  • Warning or failure (according to 2020 ELN Recommendations; Hochhaus et al) to 1L TKI therapy at the time of screening
  • 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
  • Treatment intolerance to 1L TKI,
  • BCR::ABL1IS > 0.1% at screening
  • Intolerance is defined as:
  • 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
  • Patients with newly diagnosed CML-CP (treatment with a prior TKI (imatinib, or nilotinib, or dasatinib or bosutinib) for ≤ 4 weeks is allowed)

Who cannot join

  • Previous treatment
  • With 2 or more ATP-binding site TKIs (for 2L patient cohort)
  • More than 4 weeks with 1-ATP-binding site TKIs (for 1L patient cohort)
  • Previous treatment with asciminib
  • Known presence of the T315I mutation at any time prior to study entry
  • Known second chronic phase of CML after previous progression to AP/BC
Show all 27Show fewer
  • Previous treatment with a hematopoietic stem-cell transplantation
  • Patient planning to undergo allogeneic hematopoietic stem cell transplantation
  • 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
  • History of acute pancreatitis within 1 year of study entry or past medical history of chronic pancreatitis
  • Participation in a prior investigational study within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer
  • 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
  • Pregnant or nursing (lactating) women
  • 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.
  • 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).
  • 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).
  • 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.
  • Known hypersensitivity to the study treatment.

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

United States80 sites

  • UNM

    Albuquerque, New Mexico, 87102

  • Alaska Oncology and Hematology

    Anchorage, Alaska, 99508

  • City Of Hope Atlanta

    Atlanta, Georgia, 30033

  • Emory University School of Medicine Winship Cancer Institute

    Atlanta, Georgia, 30308

  • Augusta University Georgia

    Augusta, Georgia, 30912

  • Texas Oncology P A

    Austin, Texas, 78121

  • St Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233-0271

  • Dana Farber Cancer Center

    Boston, Massachusetts, 02215

  • Rocky Mountain Cancer Centers

    Boulder, Colorado, 80304

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Onco Inst of Hope and Innovation

    Cerritos, California, 90703

  • University of North Carolina

    Chapel Hill, North Carolina, 27514

  • Novant Health Heart Vas Inst

    Charlotte, North Carolina, 28204

  • Hematology Oncology Care

    Cincinnati, Ohio, 45236

  • Care Access Research Clifton

    Clifton, New Jersey, 07013

  • University Missouri Ellis Fischel Cancer Center

    Columbia, Missouri, 65203

  • James Cancer Hospital and Solove Research Institute Ohio State

    Columbus, Ohio, 43210

  • Texas Oncology

    Dallas, Texas, 75251

  • Henry Ford Hospital

    Detroit, Michigan, 48202-2689

  • City of Hope National Medical

    Duarte, California, 91010

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Care Access Research

    Easton, Pennsylvania, 18045

  • Hackensack Meridian Health

    Edison, New Jersey, 88837

  • Florida Cancer Specialists

    Fort Myers, Florida, 33901

  • Ctr For Cancer And Blood Disorders

    Fort Worth, Texas, 76104

  • UCSF Fresno Internal Medicine

    Fresno, California, 93701

  • Virginia K Crosson Cancer Center

    Fullerton, California, 92835

  • Virginia Cancer Specialists

    Gainesville, Virginia, 20155

  • Bon Secours Cancer Center

    Greenville, South Carolina, 29607

  • Hackensack University Medical Ctr

    Hackensack, New Jersey, 07601

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Univ of TX MD Anderson Cancer Cntr

    Houston, Texas, 77030

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 42637

  • Investigative Clinicl Rsrch of Indi

    Indianapolis, Indiana, 46260

  • Holden Comp Can Cent Quad Cities U

    Iowa City, Iowa, 52242

  • Jackson Onc Associates

    Jackson, Mississippi, 39216

  • Baptist MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Nebraska Hematology Oncology P C

    Lincoln, Nebraska, 68506

  • UCLA

    Los Angeles, California, 90095

  • Dean Health System

    Madison, Wisconsin, 53717

  • Northwest Georgia Oncology Center

    Marietta, Georgia, 30060

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • NYU Langone Long Island

    Mineola, New York, 11501

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of NJ

    New Brunswick, New Jersey, 08901

  • Yale University School Of Medicine

    New Haven, Connecticut, 06520

  • Manhattan Hematol Oncol Associates

    New York, New York, 10016

  • Mt Sinai Medical Center

    New York, New York, 10029-6574

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Alta Bates Summit Medical Center

    Oakland, California, 94609

  • Community Cancer Trials of Utah

    Ogden, Utah, 84405

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • UPMC

    Pittsburgh, Pennsylvania, 15213

  • New York Bld And Cancer Specialists

    Port Jefferson, New York, 11776

  • Oregon Health Sciences University

    Portland, Oregon, 97239

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

  • Mays Cancer Center

    San Antonio, Texas, 78229

  • Texas Oncology San Antonio

    San Antonio, Texas, 78258

  • City of Hope Phoenix

    Scottsdale, Arizona, 85258

  • VA Puget Sound Health Care System

    Seattle, Washington, 98108

  • Fred Hutch Cancer Research

    Seattle, Washington, 98109

  • Louisiana State University

    Shreveport, Louisiana, 71130

  • Avera Cancer

    Sioux Falls, South Dakota, 57105

  • Siteman Cancer Center

    St Louis, Missouri, 63110

  • Florida Cancer Specialists-North

    St. Petersburg, Florida, 33705

  • The Stamford Hospital

    Stamford, Connecticut, 06904

  • SUNY Stony Brook Medical Oncology

    Stony Brook, New York, 11794-8174

  • Florida Cancer Specialists East

    Stuart, Florida, 34994

  • SUNY Upstate Medical Center

    Syracuse, New York, 13210

  • Northwest Medical Specialties

    Tacoma, Washington, 98405

  • Lundquist Inst BioMed at Harbor

    Torrance, California, 90509-2910

  • USO Arizona Oncology

    Tucson, Arizona, 85711

  • Texas Oncology Northeast Texas

    Tyler, Texas, 75702

  • Wichita Community Clcl Onco Program

    Wichita, Kansas, 67214

  • Wake Forest Uni Health Sci

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Phase II Multicenter, Open-label, Single-arm Dose Escalation Study of Asciminib Monotherapy in 2nd and 1st Line Chronic Phase - Chronic Myelogenous Leukemia (ASC2ESCALATE)

This will be a multicenter Phase II open-label study of asciminib in CML-CP patients who have been previously treated with one prior ATP- binding site TKI with discontinuation due to treatment failure, warning or intolerance. (2L patient cohort). In addition, newly diagnosed CML-CP patients who may have received up to 4 weeks of prior TKI are included in a separate 1L patient cohort.

Read the detailed description

This trial consists of three periods: screening and baseline for up to 28 days, active treatment for up to 156 weeks and a safety follow up period for 30 days.

Ninety-two (92) 2L patients with CML-CP without T315I mutation who had 1 prior ATP-binding site TKI discontinued due to treatment failure, warning or intolerance will be considered for the current study. Patients will be tested at screening for the T315I mutation and excluded if the mutation is found.

To gain additional insights into the effect of asciminib in the 1L setting, an additional cohort of newly diagnosed CML-CP patients will be enrolled in the study. Based on the number of participating sites, it is approximated that between 60 and 90 patients could be enrolled. Enrollment of the 1L cohort will be stopped when a maximum of 90 patients have been enrolled or when approximately 60 patients have been enrolled and the 2L cohort is fully recruited, whichever comes first.

Informed consent will be obtained before any procedures are performed for the study including eligibility assessments.

All eligible patients will be initially treated with asciminib at 80 mg QD. At 6 months of study treatment, patients who have achieved BCR-ABL1IS ≤1% will continue on the same dose whereas those who have not will increase dose to 200mg QD.

At 12 months of study treatment, patients will be evaluated for the primary endpoint of the study (MMR at 12 month in 2L patient cohort) and will pursue one of the following:

  • Continue on the current dose of asciminib if MMR is achieved
  • Increase dose to 200 mg QD if on 80 mg QD dosing and MMR is not achieved
  • Increase dose to 200 mg BID if on 200 mg QD dosing and MMR is not achieved
  • Take the patient off the study and switch to Investigator's agent of choice if MMR is not achieved and it is in the interest of the patient based on investigator's clinical judgment of prospect treatment benefit.
Being tested
asciminib
Keywords
CML, Chronic Phase, Asciminib, ASC2ESCALATE, T315I mutation, BCR-ABL, MMR, TKI, Tyrosine Kinase Inhibitor, molecular response, adult
Medical subject headings
Leukemia, Myeloid, Chronic-Phase

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • asciminibDrug

    Also called ABL001

    Supplied in 40 mg and 100 mg tablets for oral use to be taken daily. Dose may be increased at 6 and 12 months based on molecular response with BCR-ABL1 Polymerase Chain Reaction testing.

Study groups in NCT05384587
Study groupRoleWhat they receive
AsciminibExperimental80 mg initial oral dose taken once a day with possible dose escalation
Receives: Drug: asciminib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting

    MMR is defined as BCR::ABL1IS ≤ 0.1%. A patient will be counted as having achieved MMR at 12 month if he/she meets the MMR criterion at 12 month.

    Measured: Baseline up to 12 months

Secondary outcomes (15)

  1. Percentage of participants achieving Molecular Response 4.5 (MR4.5) at 24 and 36 months

    Percentage of participants who achieve MR4.5 (defined as a ≥ 4.5 log reduction in BCR::ABL1 transcripts compared to the standardized baseline equivalent to ≤ 0.0032% BCR::ABL1/ABL % by international scale as measured by real time Polymerase Chain Reaction [PCR]) at the specified visits, i.e., if a patient achieves an MR4.5 but then loses it before or at the visit, he/she will be considered as non-responder for MR4.5 at that time point.

    Measured: Baseline, 24 and 36 months

  2. MMR Rate at visit (other than 12 month)

    Percentage of participants who achieve MMR (defined as BCR::ABL1IS ≤ 0.1%) at the specified visit, i.e., if a patient achieves an MMR earlier but then loses it at the visit, he/she will be considered as non-responder for MMR at the specified visit

    Measured: Baseline, 3, 6, 18, 24, 30 and 36 months

  3. MR2 Rate at visit

    Percentage of participants who achieve MR2 (defined as a ≥ 2 log reduction in BCR::ABL1 transcripts) at the specified visit, i.e., if a patient achieves an MR2 earlier but then loses it at the visit, he/she will be considered as non-responder for MR2 at the specified visit

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  4. MR4 Rate at visit

    Percentage of participants who achieve MR4 (defined as a ≥ 4 log reduction in BCR::ABL1 transcripts) at the specified visit, i.e if a patient achieves an MR4 earlier, but then loses it at the visit, he/she will be considered as non-responder for MR4 at the specified visit

    Measured: Baseline, 3, 6, 12, 18, 24, 30 and 36 months

  5. MR4.5 Rate at visit

    Percentage of participants who achieve MR4.5 (defined as a ≥ 4.5 log reduction in BCR::ABL1 transcripts) at the specified visit, i.e if a patient achieves an MR4.5 earlier, but then loses it at the visit, he/she will be considered as non-responder for MR4.5 at the specified visit

    Measured: Baseline, 3, 6, 12, 18 and 30 months

  6. MMR Rate by visit

    Percentage of participants who achieve MMR at or before the specified visit, i.e., if a patient achieves an MMR but then loses it before or at the visit, he/she will still be considered as achieving MMR by that time point.

    Measured: Baseline up to 3, 6, 12, 18, 24, 30 and 36 months

  7. MR2 Rate by visit

    Percentage of participants who achieve MR2 (defined as a ≥ 2 log reduction in BCR::ABL1 transcripts) at or before the specified visit, i.e., if a patient achieves an MR2 but then loses it before or at the visit, he/she will still be considered as achieving MR2 by that time point.

    Measured: Baseline up to 3, 6, 12, 18, 24, 30 and 36 months

  8. MR4 Rate by visit

    Percentage of participants who achieve MR4 (defined as a ≥ 4 log reduction in BCR::ABL1 transcripts) at or before the specified visit, i.e., if a patient achieves an MR4 but then loses it before or at the visit, he/she will still be considered as achieving MR4 by that time point.

    Measured: Baseline up to 3, 6, 12, 18, 24, 30 and 36 months

  9. MR4.5 Rate by visit

    Percentage of participants who achieve MR4.5 (defined as a ≥ 4.5 log reduction in BCR::ABL1 transcripts) at or before the specified visit, i.e., if a patient achieves an MR4.5 but then loses it before or at the visit, he/she will still be considered as achieving MR4.5 by that time point.

    Measured: Baseline up to 3, 6, 12, 18, 24, 30 and 36 months

  10. Time to MMR

    Time to MMR is defined and calculated as date of first documented MMR - start date of study treatment +1 day.

    Measured: Baseline up to 36 months

  11. Duration of MMR

    Duration of MMR is defined as the time from the date of first documented MMR to the earliest date of loss of MMR, progression to Accelerated Phase (AP) or Blast Crisis (BC), or CML-related death.

    Measured: Baseline up to 36 months

  12. Time to Treatment Failure (TTF)

    Time to treatment failure (TTF) is defined as the time from date of randomization to an event of treatment failure.

    Measured: Baseline up to 36 months

  13. Progression Free Survival (PFS)

    Time from the first dose of study treatment to the earliest occurrence of documented progression to Accelerated Phase (AP) or Blast Crisis (BC) or the date of death from any cause, before the end of the treatment phase.

    Measured: Baseline up to 36 months

  14. Overall Survival (OS)

    Time from the first dose of study treatment to death due to any cause during the study.

    Measured: Baseline up to 36 months.

  15. Number of Adverse Events and Serious Adverse Events

    Clinically significant findings for vitals, laboratory values and electrocardiogram (ECG) will be reported as adverse events and or serious adverse events as determined by the investigator.

    Measured: Baseline up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2022
  2. Study start11 Nov 2022
  3. Primary completion13 Aug 2025
  4. Study completion17 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05384587
Sponsor's protocol ID
CABL001AUS08
Acronym
ASC2ESCALATE
Status last verified
Oct 2025
First submitted
17 May 2022
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Atallah EL, Mauro MJ, Sasaki K, Levy MY, Koller P, Yang D, Laine D, Sabo J, Gu E, Cortes JE. Dose-escalation of second-line and first-line asciminib in chronic myeloid leukemia in chronic phase: the ASC2ESCALATE Phase II trial. Future Oncol. 2024;20(38):3065-3075. doi: 10.1080/14796694.2024.2402680. Epub 2024 Oct 10.

    PubMed 39387441

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing asciminib in people with Chronic Myelogenous Leukemia - Chronic Phase, run by Novartis Pharmaceuticals at 80 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting (time frame: Baseline up to 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05384587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2025.

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