Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia (ASC2ESCALATE)

April 20, 2024 updated by: Novartis Pharmaceuticals

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial consists of three periods: screening and baseline for up to 28 days, active treatment for up to 104 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.

Study Type

Interventional

Enrollment (Estimated)

182

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Novartis Pharmaceuticals

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233-0271
        • Recruiting
        • University of Alabama at Birmingham .
        • Principal Investigator:
          • Omer Jamy
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology and Hematology
        • Principal Investigator:
          • Steven Liu
        • Contact:
          • Phone Number: 907-279-3155
    • Arizona
      • Scottsdale, Arizona, United States, 85258
        • Recruiting
        • City of Hope Phoenix
        • Principal Investigator:
          • Schriber Jeffrey
      • Tucson, Arizona, United States, 85711
        • Recruiting
        • USO Arizona Oncology
        • Principal Investigator:
          • Manda Sudhir
    • California
      • Cerritos, California, United States, 90703
        • Recruiting
        • Onco Inst of Hope and Innovation
        • Contact:
          • Phone Number: +1 562 698 6888
        • Principal Investigator:
          • Arati Rani Chand
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical
        • Principal Investigator:
          • Paul Koller
        • Contact:
          • Phone Number: +16262564673#85013
      • Fresno, California, United States, 93701
        • Recruiting
        • UCSF Fresno Internal Medicine
        • Principal Investigator:
          • Haifaa Abdulhaq
        • Contact:
          • Phone Number: 599-499-6566
      • Fullerton, California, United States, 92835
        • Recruiting
        • Virginia K Crosson Cancer Center
        • Principal Investigator:
          • Steven Kim
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA
        • Principal Investigator:
          • Gary Schiller
      • Torrance, California, United States, 90509-2910
        • Recruiting
        • Lundquist Inst BioMed at Harbor .
        • Principal Investigator:
          • Sarah Tomassetti
    • Colorado
      • Boulder, Colorado, United States, 80304
        • Recruiting
        • Rocky Mountain Cancer Centers USOR
        • Contact:
          • Phone Number: 303-385-2000
        • Principal Investigator:
          • David J Andorsky
    • Connecticut
      • Stamford, Connecticut, United States, 06904
        • Recruiting
        • The Stamford Hospital
        • Contact:
          • Phone Number: 203-358-8879
        • Principal Investigator:
          • Kelsey Sokol
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Recruiting
        • Florida Cancer Specialists
        • Contact:
          • Phone Number: 239-274-9930
        • Principal Investigator:
          • Blessy Jacob
      • Jacksonville, Florida, United States, 32207
        • Recruiting
        • Baptist MD Anderson Cancer Center
        • Contact:
          • Phone Number: 614-657-1463
        • Principal Investigator:
          • Maxim Norkin
      • Saint Petersburg, Florida, United States, 33705
        • Recruiting
        • Florida Cancer Specialists-North
        • Principal Investigator:
          • Gustavo Adolfo Fonseca
        • Contact:
          • Phone Number: +1 727 216 1143
      • Stuart, Florida, United States, 34994
        • Recruiting
        • Florida Cancer Specialists East
        • Principal Investigator:
          • Shachar Peles
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University School of Medicine/Winship Cancer Institute
        • Contact:
          • Phone Number: 404-686-2505
        • Principal Investigator:
          • Anthony Michael Hunter
      • Atlanta, Georgia, United States, 30033
        • Recruiting
        • City Of Hope Atlanta
        • Principal Investigator:
          • Sabarish Ayyappan
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University Georgia .
        • Contact:
          • Phone Number: 404-778-1900
        • Principal Investigator:
          • Jorge Cortes
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Center .
        • Principal Investigator:
          • Steve McCune
        • Contact:
          • Phone Number: 770-281-5124
    • Indiana
      • Indianapolis, Indiana, United States, 42637
        • Recruiting
        • Franciscan Health Indianapolis
        • Principal Investigator:
          • John Edwards
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Investigative Clinicl Rsrch of Indi
        • Principal Investigator:
          • Brian Mulherin
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Recruiting
        • Wichita Community Clcl Onco Program Oncology
        • Principal Investigator:
          • Shaker R Dakhil
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Recruiting
        • University of Kentucky
        • Principal Investigator:
          • Reinhold Munker
        • Contact:
          • Phone Number: 859-218-5151
    • Louisiana
      • Shreveport, Louisiana, United States, 71130
        • Recruiting
        • Louisiana State University Main Centre
        • Principal Investigator:
          • Poornima Ramadas
        • Contact:
          • Phone Number: 318-675-5960
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Center .
        • Principal Investigator:
          • Marlise Luskin
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • Recruiting
        • Jackson Onc Associates
        • Principal Investigator:
          • Thomas Williamson
    • Missouri
      • Columbia, Missouri, United States, 65203
        • Recruiting
        • University Missouri Ellis Fischel Cancer Center
        • Contact:
          • Phone Number: 573-882-4979
        • Principal Investigator:
          • Hildebrandt Gerhard
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Siteman Cancer Center .
        • Principal Investigator:
          • Camille N Abboud
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St Vincent Frontier Cancer Center
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
          • Phone Number: 406-238-6962
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • Nebraska Hematology-Oncology, P.C.
        • Principal Investigator:
          • Kailash Mosalpuria
        • Contact:
          • Phone Number: 402-484-4908
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock Medical Center
        • Principal Investigator:
          • Swaroopa Yerrabothala
        • Contact:
          • Phone Number: 603-650-6228
    • New Jersey
      • Clifton, New Jersey, United States, 07013
        • Recruiting
        • Care Access Research Clifton
        • Principal Investigator:
          • Richards Afjonja
      • Edison, New Jersey, United States, 88837
        • Recruiting
        • Hackensack Meridian Health Research
        • Principal Investigator:
          • Evan Naylor
      • Hackensack, New Jersey, United States, 07601
        • Recruiting
        • Hackensack University Medical Ctr
        • Principal Investigator:
          • James McCloskey
        • Contact:
          • Phone Number: 201-996-5900
      • New Brunswick, New Jersey, United States, 08903
        • Recruiting
        • Rutgers Cancer Institute of New Jersey
        • Contact:
          • Phone Number: 732-235-6031
        • Principal Investigator:
          • Dale Schaar
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Recruiting
        • UNM
        • Principal Investigator:
          • Charles Foucar
    • New York
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Clinical Research Alliance Research
        • Principal Investigator:
          • James D Olimpio
        • Contact:
          • Phone Number: +1 516 488 2918#183
      • Mineola, New York, United States, 11501
        • Recruiting
        • NYU Langone Long Island
        • Principal Investigator:
          • Kiner-Strachan Bonnie
      • New York, New York, United States, 10016
        • Recruiting
        • Manhattan Hematol Oncol Associates
        • Principal Investigator:
          • Alec Goldenberg
      • Port Jefferson Station, New York, United States, 11776
        • Recruiting
        • New York Bld And Cancer Specialists
        • Principal Investigator:
          • Richard Zuniga
      • Stony Brook, New York, United States, 11794-8174
        • Recruiting
        • SUNY Stony Brook Medical Oncology
        • Contact:
          • Phone Number: 516-444-7863
        • Principal Investigator:
          • Michael A. Schuster
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical Center
        • Contact:
          • Phone Number: 315-464-4353
        • Principal Investigator:
          • Teresa C Gentile
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • Uni of North Carolina Hospital
        • Contact:
          • Phone Number: 919-966-4131
        • Principal Investigator:
          • Josh Zeidner
      • Charlotte, North Carolina, United States, 28204
        • Recruiting
        • Novant Health Heart and Vascular Institute .
        • Principal Investigator:
          • James Dugan
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center .
        • Principal Investigator:
          • Lindsay Rein
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest Uni Health Sci Oncology
        • Principal Investigator:
          • Bayard L. Powell
        • Contact:
          • Phone Number: 336-716-7972
    • Ohio
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • Hematology Oncology Care
        • Contact:
          • Phone Number: 513-751-2273
        • Principal Investigator:
          • Kruti Patel
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health Sciences University .
        • Principal Investigator:
          • Michael Charles Heinrich
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University
        • Principal Investigator:
          • Lindsay Wilde
        • Contact:
          • Phone Number: 215-955-2432
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Bon Secours Cancer Center
        • Contact:
          • Phone Number: +1 864 603 6214
        • Principal Investigator:
          • Robert David Siegel
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera Cancer Avera Cancer Institute
        • Principal Investigator:
          • Xavier Andrade-Gonzalez
        • Contact:
          • Phone Number: 605-322-3291
    • Texas
      • Austin, Texas, United States, 78121
        • Recruiting
        • Texas Oncology, P.A.
        • Principal Investigator:
          • Jason M Melear
        • Contact:
          • Phone Number: 512-324-7991
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Texas Oncology TX Oncology Baylor
        • Contact:
          • Phone Number: +1 214 370 1000
        • Principal Investigator:
          • Moshe Yair Levy
      • Fort Worth, Texas, United States, 76104
        • Recruiting
        • Ctr For Cancer And Blood Disorders
        • Contact:
          • Phone Number: 817-759-7030
        • Principal Investigator:
          • Latha Polavaram
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Principal Investigator:
          • Shilpan Shah
        • Contact:
          • Phone Number: 346-238-5685
      • Houston, Texas, United States, 77030
        • Recruiting
        • Univ of TX MD Anderson Cancer Cntr
        • Contact:
          • Phone Number: 713-792-2828
        • Principal Investigator:
          • Koji Sasaki
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Mays Cancer Center
        • Contact:
          • Phone Number: 210-450-1887
        • Principal Investigator:
          • Zohra Nooruddin
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • Texas Oncology San Antonio TO San Antonio
        • Principal Investigator:
          • John Renshaw
      • Tyler, Texas, United States, 75702
        • Recruiting
        • Texas Oncology Northeast Texas
        • Contact:
          • Phone Number: 903-579-9867
        • Principal Investigator:
          • Habte Yimer
    • Utah
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Community Cancer Trials of Utah
        • Principal Investigator:
          • Carl Gray
        • Contact:
          • Phone Number: 801-689-3909
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute .
        • Principal Investigator:
          • Srinivas Tantravahi
    • Virginia
      • Gainesville, Virginia, United States, 20155
        • Recruiting
        • Virginia Cancer Specialists
        • Principal Investigator:
          • Mitul Gandhi
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates VOA - Lake Wright
        • Contact:
          • Phone Number: 757-213-5637
        • Principal Investigator:
          • Celeste Bremer
    • Washington
      • Seattle, Washington, United States, 98108
        • Recruiting
        • VA Puget Sound Health Care System
        • Contact:
          • Phone Number: 800-329-8387
        • Principal Investigator:
          • Robert Richard
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch Cancer Research
        • Contact:
          • Phone Number: 206-667-5000
        • Principal Investigator:
          • Vivian Oehler
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties
        • Contact:
          • Phone Number: 253-428-8756
        • Principal Investigator:
          • Frank Senecal
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin
        • Contact:
          • Phone Number: 414-805-5249
        • Principal Investigator:
          • Ehab Atallah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 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: loss of MMR 7. Beyond 12 months after the initiation of to 1L TKI, a. BCR-ABL1IS > 0.1% at screening b. 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 randomization 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Asciminib
80 mg initial oral dose taken once a day with possible dose escalation
Drug: asciminib
Supplied in 40 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.
Other Names:
  • ABL001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants who achieve Major Molecular Response (MMR) in the 2L setting
Time Frame: Baseline up to 12 months
MMR is defined as BCR-ABL1IS ≤ 0.1%).
Baseline up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participants achieving Molecular Response (MR4.5)
Time Frame: Baseline up to 24 months
Molecular response (MR) will be assessed. The rate of MR4.5 where MR4.5 is 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).
Baseline up to 24 months
Number of Adverse Events and Serious Adverse Events
Time Frame: Baseline up to 24 months
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.
Baseline up to 24 months
MMR Rate - All scheduled time points
Time Frame: Baseline up to 3, 6, 18, and 24 months
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, h/she will still be considered as achieving MMR by that time point.
Baseline up to 3, 6, 18, and 24 months
Time to MMR
Time Frame: Baseline up to 24 months
Time to MMR is defined and calculated as date of first documented MMR - start date of study treatment +1 day.
Baseline up to 24 months
Duration of MMR
Time Frame: Baseline up to 24 months
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.
Baseline up to 24 months
Time to Treatment Failure (TTF)
Time Frame: Baseline up to 24 months
Time to treatment failure (TTF) is defined as the time from date of randomization to an event of treatment failure.
Baseline up to 24 months
Progression Free Survival (PFS)
Time Frame: Baseline up to 24 months
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.
Baseline up to 24 months
Overall Survival (OS)
Time Frame: Baseline up to 24 months.
Time from the first dose of study treatment to death due to any cause during the study.
Baseline up to 24 months.
MR2 Rate - All scheduled time points
Time Frame: Baseline up to 3, 6, 12, 18, and 24 months
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 MMR but then loses it before or at the visit, h/she will still be considered as achieving MR2 by that time point.
Baseline up to 3, 6, 12, 18, and 24 months
MR4 Rate - All scheduled time points
Time Frame: Baseline up to 3, 6, 12, 18, and 24 months
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 MMR but then loses it before or at the visit, h/she will still be considered as achieving MR4 by that time point.
Baseline up to 3, 6, 12, 18, and 24 months
MR4.5 Rate - All scheduled time points
Time Frame: Baseline up to 3, 6, 12, and 18
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 MMR but then loses it before or at the visit, h/she will still be considered as achieving MR4.5 by that time point.
Baseline up to 3, 6, 12, and 18

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
To investigate MR2, MR4, MR4.5 rate at visit
Time Frame: Baseline up to 24 months
MR2, MR4 and MR4.5 at all scheduled data collection time points except for MR4.5 at 24 month
Baseline up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Daisy Yang, PhD, Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 11, 2022

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

February 26, 2027

Study Registration Dates

First Submitted

May 17, 2022

First Submitted That Met QC Criteria

May 17, 2022

First Posted (Actual)

May 20, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 20, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CABL001AUS08

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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