ASC2ESCALATE (CABL001AUS08) = Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia [USA]
Study title
ASC2ESCALATE = Asciminib Monotherapy, With Dose Escalation, for 2nd and 1st Line Chronic Myelogenous Leukemia
Scientific 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
Type of study
Trial after therapy failure or intolerance
Phase
Current status
Recruiting
Other trial ID
CABL001AUS08; ClinicalTrials.gov NCT05384587
What is the purpose of the study
This is a study to evaluate oral asciminib in patients with CML in chronic phase (CP) who have been previously treated with one prior ATP- binding site tyrosine kinase inhibitor (TKI) with discontinuation due to treatment failure, warning or intolerance [second line (2L) patient cohort].
This study also gains insights into the effect of asciminib when used in first line (1L) treatment. To this end, newly diagnosed CML-CP patients who may have received a TKI for up to 4 weeks are included in a separate 1L patient cohort.
What will happen during the study
This trial consists of three periods: screening and baseline for up to 28 days, treatment with ascimib for up to 104 weeks and a safety follow up period for 30 days.
Patients with CML-CP without T315I mutation who had received 1 prior ATP-binding site TKI will be considered for inclusion in the 2L patient cohort of this trial.
In addition, newly diagnosed CML-CP patients will be considered for inclusion in a separate 1L patient cohort.
All eligible patients will initially receive asciminib 80 mg once daily. At 6 months of study treatment, patients who have achieved BCR-ABL1IS ≤1% will continue on the same dose whereas those who have not achieved this will increase their dose to 200 mg once daily.
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). They will then:
- continue on the current dose of asciminib if MMR is achieved, or
- increase dose to 200 mg once daily if they are on 80 mg once daily dosing and have not achieved MMR, or
- increase dose to 200 mg twice daily if they are on 200 mg once daily dosing and have not achieved MMR, or
- be taken off the study and switched 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.
Key inclusion criteria
This study includes patients of all sexes who:
- are aged 18 years or older
- have chronic myelogenous leukemia in chronic phase (CML-CP), no previous accelerated phase (AP) or blast crisis (BC)
- have an Eastern Co-Operative Group (ECOG) status of 0, 1 or 2
- have adequate end organ function within 14 days before the first dose of asciminib treatment.
Further criteria apply. Please discuss these with your doctor or study staff.
Key exclusion criteria
This study does not include patients who:
- have been treated
– with 2 or more ATP-binding site TKIs (for second line patient cohort)
– more than 4 weeks with 1-ATP-binding site TKIs (for first line patient cohort) - have been treated previously with asciminib
- have known presence of a T315I mutation at any time before study entry
- have a known second chronic phase of CML after previous progression to AP/BC.
Further criteria apply. Please discuss these with your doctor or study staff.
Estimated primary completion date
Where can I find additional information
You can find a study description in the US registry ClinicalTrials.gov. This is a database provided by the U. S. National Institutes of Health.
Study sponsor
Novartis Pharmaceuticals
Scientific lead / contact
Novartis Pharmaceuticals
Principal investigator
Novartis Pharmaceuticals
Study centers / principal investigators
United States
Alabama
University of Alabama at Birmingham
Birmingham, Alabama, 35233-0271
Principal Investigator: Omer Jamy
Alaska
Alaska Oncology and Hematology
Anchorage, Alaska, 99508
Principal Investigator: Steven Liu
California
Onco Inst of Hope and Innovation
Cerritos, California, 90703
Principal Investigator: Arati Rani Chand
City of Hope National Medical
Duarte, California, 91010
Principal Investigator: Paul Koller
UCSF Fresno Internal Medicine
Fresno, California, 93701
Principal Investigator: Haifaa Abdulhaq
Virginia K Crosson Cancer Center
Fullerton, California, 92835
Principal Investigator: Steven Kim
UCLA
Los Angeles, California, 90095
Principal Investigator: Gary Schiller
Lundquist Inst BioMed at Harbor
Torrance, California, 90509-2910
Principal Investigator: Sarah Tomassetti
Colorado
Rocky Mountain Cancer Centers USOR
Bolder, Colorado, 80304
Principal Investigator: David J. Andorsky
Florida
Florida Cancer Specialists
Fort Myers, Florida, 33901
Principal Investigator: Blessy Jacob
Baptist MD Anderson Cancer Center
Jacksonville, Florida, 32207
Principal Investigator: Maxim Norkin
Florida Cancer Specialists North
Saint Petersburg, Florida, 33705
Principal Investigator: Gustavo Alfonso Fonseca
Florida Cancer Specialists East
Stuart, Florida, 34994
Principal Investigator: Shachar Peles
Georgia
Emory University School of Medicine/Winship Cancer Institute
Atlanta, Georgia, 30308
Principal Investigator: Anthony Michael Hunter
Augusta University Georgia
Augusta, Georgia, 30912
Principal Investigator: Jorge Cortes
Northwest Georgia Oncology Center
Marietta, Georgia, 30060
Principal Investigator: Steve McCune
Indiana
Franciscan Health Indianapolis
Indianapolis, Indiana, 42637
Principal Investigator: Brian Mulherin
Kansas
Wichita Community CIcI Onco Program Oncology
Wichita, Kansas, 67214
Principal Investigator: Shaker R Dakhil
Kentucky
University of Kentucky
Lexington, Kentucky, 40536
Principal Investigator: Reinhold Munker
Louisiana
Louisiana State University Main Centre
Shreveport, Louisiana, 71130
Principal Investigator: Poornima Ramadas
Massachusetts
Dana Farber Cancer Center
Boston, Massachusetts, 02215
Principal Investigator: Marlise Luskin
Mississippi
Jackson Onc Associates
Jackson, Mississippi, 39216
Principal Investigator: Thomas Williamson
Missouri
University Missouri Ellis Fischel Cancer Center
Columbia, Missouri, 65203
Principal Investigator: Hildebrandt Gerhard
Siteman Cancer Center
Saint Louis, Missouri, 63110
Principal Investigator: Camille N Abboud
Montana
St Vincent Frontier Cancer Center
Billings, Montana, 59102
Principal Investigator: Patrick Cobb
New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Principal Investigator: Swaroopa Yerrabothala
New Jersey
Hackensack Meridian Health Research
Brick, New Jersey, 08724
Principal Investigator: Evan Naylor
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Principal Investigator: James McCloskey
Care Access Research Clifton
Clifton, New Jersey, 07013
Principal Investigator: Richards Afjonja
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Principal Investigator: Dale Schaar
New Mexico
UNM
Albuquerque, New Mexico, 87102
Principal Investigator: Charles Foucar
New York
Clinical Research Alliance Research
Lake Success, New York, 11042
Principal Investigator: James D Olimpio
NYU Langone Long Island
Mineola, New York, 11501
Principal Investigator: Kiner-Strachan Bonnie
Manhattan Hematol Oncol Associates
New York, New York, 10016
Principal Investigator: Alec Goldenberg
SUNY Stony Brook Medical Oncology
Stony Brook, New York, 11794-8174
Principal Investigator: Michael A Schuster
SUNY Upstate Medical Center
Syracuse, New York, 13210
Principal Investigator: Teresa C Gentile
North Carolina
University of North Carolina Hospital
Chapel Hill, North Carolina, 27514
Principal Investigator: Josh Zeidner
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Principal Investigator: James Dugan
Duke University Medical Center
Durham, North Carolina, 27710
Principal Investigator: Lindsay Rein
Wake Forest University Health Sciences Oncology
Winston-Salem, North Carolina, 27157
Principal Investigator: Bayard L. Powell
Ohio
Hematology Oncology Care
Cincinnati, Ohio, 45236
Principal Investigator: Kruti Patel
Oregon
Oregon Health and Sciences University
Portland, Oregon, 97239
Principal Investigator: Michael Charles Heinrich
Texas
Texas Oncology P A TX Oncology Baylor
Dallas, Texas, 752521
Principal Investigator: Moshe Yair Levy
Houston Methodist Hospital
Houston, Texas, 77030
Principal Investigator: Shilpan Shah
University of TX MD Anderson Cancer Center
Houston, Texas, 77030
Principal Investigator: Koji Sasaki
Mays Cancer Center
San Antonio, Texas, 78229
Principal Investigator: Zohra Nooruddin
Utah
Community Cancer Trials of Utah
Ogden, Utah, 84405
Principal Investigator: Carl Gray
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
Principal Investigator: Srinivas Tantravahi
Virginia
Virginia Cancer Specialists
Gainesville, Virginia, 20155
Principal Investigator: Mitul Gandhi
Virginia Oncology Associates VOA – Lake Wright
Norfolk, Virginia, 23502
Principal Investigator: Robert Richard
Washington
VA Puget Sound Health Care System
Seattle, Wisconsin, 98108
Principal Investigator: Ehab Atallah
Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Principal Investigator: Ehab Atallah