A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase

Who is this study for? Patients with newly diagnosed Philadelphia chromosome positive chronic myelogenous leukemia in chronic phase
What treatments are being studied? Asciminib
Status: Recruiting
Location: See all (145) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

The study is designed to compare the efficacy of asciminib 80 mg QD versus Investigator selected TKI for the treatment of newly diagnosed, previously untreated patients with Ph+ CML-CP. The Investigator selected TKI will be one of the following treatment options for first-line treatment of CML-CP - imatinib 400 mg QD or nilotinib 300 mg BID or dasatinib 100 mg QD or bosutinib 400 mg QD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

‣ 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 109/L (≥ 100,000/mm3),

‣ No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.

⁃ Eastern Cooperative Oncology Group (ECOG) performance status of 0,or 1. 5. 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 6. 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 7. 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.

Locations
United States
California
City of Hope National Medical Center
Recruiting
Duarte
UCLA Medical Center
Recruiting
Los Angeles
Colorado
Rocky Mountain Cancer Centers
Recruiting
Longmont
Florida
Florida Cancer Specialists
Recruiting
Fort Myers
Florida Cancer Specialists Dept of Oncology (2)
Recruiting
Fort Myers
Florida Cancer Specialists Panhandle
Recruiting
Tallahassee
Florida Cancer Specialists
Recruiting
West Palm Beach
Iowa
University of Iowa Hospitals and Clinics Univ of Iowa Hosp & Clinic
Recruiting
Iowa City
Illinois
University of Chicago
Recruiting
Chicago
Illinois Cancer Care P.C. IL Cancer Specialists
Recruiting
Peoria
Kentucky
University of Kentucky
Recruiting
Lexington
Massachusetts
University of Massachusetts Medical Center Dept of Oncology
Recruiting
Worcester
Michigan
University of Michigan Clinical Trials Office
Recruiting
Ann Arbor
North Carolina
Wake Forest University Baptist Medical Center Comprehensive Cancer Ctr
Recruiting
Winston-salem
Ohio
Oncology Hematology Care Inc
Recruiting
Cincinnati
Oregon
Williamette Cancer Center
Recruiting
Eugene
South Dakota
Avera Cancer Avera Cancer Institute
Recruiting
Sioux Falls
Tennessee
Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga
Recruiting
Chattanooga
Texas
Texas Oncology
Recruiting
Dallas
Texas Oncology P A Austin
Recruiting
Dallas
Texas Oncology Texas Onc - Amarillo
Recruiting
Dallas
Texas Oncology-Baylor USO
Recruiting
Dallas
University of TX MD Anderson Cancer Center
Recruiting
Houston
Lumi Research
Recruiting
Kingwood
Texas Oncology Northeast Texas
Recruiting
Tyler
Virginia
Virginia Cancer Specialists
Recruiting
Gainesville
Virginia Oncology Associates
Recruiting
Norfolk
Other Locations
Australia
Novartis Investigative Site
Recruiting
Adelaide
Novartis Investigative Site
Recruiting
Kingswood
Novartis Investigative Site
Recruiting
Port Macquarie
Novartis Investigative Site
Recruiting
Southport
Novartis Investigative Site
Recruiting
Woolloongabba
Austria
Novartis Investigative Site
Recruiting
Linz
Novartis Investigative Site
Recruiting
Wien
Belgium
Novartis Investigative Site
Recruiting
Bruxelles
Novartis Investigative Site
Recruiting
Hasselt
Novartis Investigative Site
Recruiting
Leuven
Bulgaria
Novartis Investigative Site
Recruiting
Sofia
Novartis Investigative Site
Recruiting
Varna
Canada
Novartis Investigative Site
Recruiting
Calgary
Novartis Investigative Site
Recruiting
Hamilton
Novartis Investigative Site
Recruiting
Ottawa
Novartis Investigative Site
Recruiting
Toronto
China
Novartis Investigative Site
Recruiting
Beijing
Novartis Investigative Site
Recruiting
Beijing
Novartis Investigative Site
Recruiting
Chengdu
Novartis Investigative Site
Recruiting
Chifeng
Novartis Investigative Site
Recruiting
Chongqing
Novartis Investigative Site
Recruiting
Guangzhou
Novartis Investigative Site
Recruiting
Hangzhou
Novartis Investigative Site
Recruiting
Hefei
Novartis Investigative Site
Recruiting
Lanzhou
Novartis Investigative Site
Recruiting
Nanjing
Novartis Investigative Site
Recruiting
Nantong
Novartis Investigative Site
Recruiting
Shanghai
Novartis Investigative Site
Recruiting
Shenzhen
Novartis Investigative Site
Recruiting
Suzhou
Novartis Investigative Site
Recruiting
Taiyuan
Novartis Investigative Site
Recruiting
Tianjin
Novartis Investigative Site
Recruiting
Wenzhou
Novartis Investigative Site
Recruiting
Wuhan
Novartis Investigative Site
Recruiting
Xian
Novartis Investigative Site
Recruiting
Zhengzhou
Denmark
Novartis Investigative Site
Recruiting
Aarhus
Novartis Investigative Site
Recruiting
Copenhagen
Novartis Investigative Site
Recruiting
Roskilde
Finland
Novartis Investigative Site
Recruiting
Helsinki
Novartis Investigative Site
Recruiting
Turku
France
Novartis Investigative Site
Recruiting
Bordeaux
Novartis Investigative Site
Recruiting
Lyon Cedex
Novartis Investigative Site
Recruiting
Nantes Cedex 1
Novartis Investigative Site
Recruiting
Paris Cedex 10
Germany
Novartis Investigative Site
Recruiting
Aachen
Novartis Investigative Site
Recruiting
Berlin
Novartis Investigative Site
Recruiting
Frankfurt
Novartis Investigative Site
Recruiting
Jena
Novartis Investigative Site
Recruiting
Luebeck
Novartis Investigative Site
Recruiting
Mannheim
Hungary
Novartis Investigative Site
Recruiting
Debrecen
Novartis Investigative Site
Recruiting
Kaposvar
Novartis Investigative Site
Recruiting
Kecskemet
India
Novartis Investigative Site
Recruiting
Delhi
Novartis Investigative Site
Recruiting
Kolkata
Israel
Novartis Investigative Site
Recruiting
Petah Tikva
Novartis Investigative Site
Recruiting
Ramat Gan
Novartis Investigative Site
Recruiting
Tel Aviv
Italy
Novartis Investigative Site
Recruiting
Bologna
Novartis Investigative Site
Recruiting
Milano
Novartis Investigative Site
Recruiting
Reggio Emilia
Novartis Investigative Site
Recruiting
Roma
Novartis Investigative Site
Recruiting
Verona
Japan
Novartis Investigative Site
Recruiting
Akita
Novartis Investigative Site
Recruiting
Chuo-city
Novartis Investigative Site
Recruiting
Fukuoka City
Novartis Investigative Site
Recruiting
Fukushima City
Novartis Investigative Site
Recruiting
Kashiwa
Novartis Investigative Site
Recruiting
Kobe-city
Novartis Investigative Site
Recruiting
Kurashiki-city
Novartis Investigative Site
Recruiting
Nagoya
Novartis Investigative Site
Recruiting
Osaka
Novartis Investigative Site
Recruiting
Osaka Sayama
Novartis Investigative Site
Recruiting
Sapporo City
Novartis Investigative Site
Recruiting
Shimotsuke
Novartis Investigative Site
Recruiting
Suita
Novartis Investigative Site
Recruiting
Sunto Gun
Novartis Investigative Site
Recruiting
Toyoake City
Novartis Investigative Site
Recruiting
Yamagata
Malaysia
Novartis Investigative Site
Recruiting
Kuantan
Novartis Investigative Site
Recruiting
Pulau Pinang
Novartis Investigative Site
Recruiting
Selangor
Novartis Investigative Site
Recruiting
Subang Jaya
Netherlands
Novartis Investigative Site
Recruiting
Amsterdam
Norway
Novartis Investigative Site
Recruiting
Bergen
Novartis Investigative Site
Recruiting
Oslo
Novartis Investigative Site
Recruiting
Trondheim
Portugal
Novartis Investigative Site
Recruiting
Lisboa
Novartis Investigative Site
Recruiting
Porto
Novartis Investigative Site
Recruiting
Vila Nova De Gaia
Republic of Korea
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Seoul
Novartis Investigative Site
Recruiting
Uijeongbu Si
Russian Federation
Novartis Investigative Site
Withdrawn
Moscow
Novartis Investigative Site
Recruiting
Saint Petersburg
Singapore
Novartis Investigative Site
Recruiting
Singapore
Novartis Investigative Site
Recruiting
Singapore
Slovakia
Novartis Investigative Site
Recruiting
Bratislava
Novartis Investigative Site
Recruiting
Kosice
Spain
Novartis Investigative Site
Recruiting
Badalona
Novartis Investigative Site
Recruiting
Barcelona
Novartis Investigative Site
Recruiting
El Palmar
Novartis Investigative Site
Recruiting
Granada
Novartis Investigative Site
Recruiting
Madrid
Novartis Investigative Site
Recruiting
Pamplona
Sweden
Novartis Investigative Site
Recruiting
Goteborg
Novartis Investigative Site
Recruiting
Lund
Novartis Investigative Site
Recruiting
Stockholm
Switzerland
Novartis Investigative Site
Recruiting
Bellinzona
Novartis Investigative Site
Recruiting
Zürich
Taiwan
Novartis Investigative Site
Recruiting
Kaohsiung City
Novartis Investigative Site
Recruiting
Taichung
United Kingdom
Novartis Investigative Site
Recruiting
London
Novartis Investigative Site
Recruiting
Nottingham
Novartis Investigative Site
Recruiting
Oxford
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: October 6, 2021
Estimated Completion Date: December 5, 2028
Participants
Target number of participants: 402
Treatments
Experimental: Asciminib
Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs
Active Comparator: Investigator selected TKIs
Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments:~Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

Similar Clinical Trials