A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

Who is this study for? Patients with Leukemia, Hematologic Diseases
Status: Recruiting
Location: See all (46) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

To evaluate efficacy, safety and pharmacokinetic profile of asciminib 40mg+imatinib or asciminib 60mg+imatinib versus continued imatinib and versus nilotinib versus asciminib 80mg in pre-treated patients with Chronic Myeloid Leukemia in chronic phase (CML-CP)

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

• Male or female patients ≥ 18 years of age with a confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase (CML-CP).

• Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 400 mg QD at randomization and had no dose change in the past three months).

• For Korea only: (i)a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.1%, ≤ 1% IS at the time of randomization. (ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.01%, ≤ 0.1% IS at the time of randomization.

• BCR-ABL1 levels > 0.01% IS (International Scale) and ≤ 1% IS at the time of randomization as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) confirmed by 2 consecutive tests at any time during prior imatinib treatment. An isolated, single test result with BCR-ABL1 levels < 0.01 % (MR4 IS) is allowed, however, it should not have been observed within the 9 months prior to randomization

• Patient must meet the following laboratory values before randomization:

• Absolute Neutrophil Count ≥ 1.5 x 10E9/L

• Platelets ≥ 75 x 10E9/L

• Hemoglobin ≥ 9 g/dL

• Serum creatinine < 1.5 mg/dL

• Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal) except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN

• Aspartate transaminase (AST) ≤ 3.0 x ULN

• Alanine transaminase (ALT) ≤ 3.0 x ULN

• Alkaline phosphatase ≤ 2.5 x ULN

• Serum lipase ≤ 1.5 x ULN

• Patients must have the following laboratory values ≥ Lower Limit of Normal or corrected to within normal limits with supplements prior to randomization: potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance within normal limits ; calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance* within normal limits) ; magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance within normal limits.

Locations
United States
Georgia
Georgia Regents University
Recruiting
Augusta
Illinois
University of Chicago
Recruiting
Chicago
Maryland
Saint Agnes Healthcare Cancer Institute
Withdrawn
Baltimore
Sidney Kimmel Comprehensive Cancer Center
Completed
Baltimore
New York
SUNY Stony Brook Medical Oncology Hematology/Oncology
Withdrawn
Stony Brook
Texas
University of Texas MD Anderson Cancer Center
Withdrawn
Houston
Other Locations
Australia
Novartis Investigative Site
Withdrawn
Adelaide
Novartis Investigative Site
Withdrawn
Darlinghurst
Novartis Investigative Site
Withdrawn
Melbourne
Austria
Novartis Investigative Site
Withdrawn
Graz
Novartis Investigative Site
Recruiting
Wien
Canada
Novartis Investigative Site
Recruiting
Montreal
Chile
Novartis Investigative Site
Withdrawn
Temuco
Novartis Investigative Site
Withdrawn
Vina Del Mar
Denmark
Novartis Investigative Site
Active, not recruiting
Copenhagen
France
Novartis Investigative Site
Active, not recruiting
Bordeaux
Germany
Novartis Investigative Site
Withdrawn
Berlin
Novartis Investigative Site
Completed
Dresden
Novartis Investigative Site
Withdrawn
Mannheim
Hong Kong Special Administrative Region
Novartis Investigative Site
Withdrawn
Hong Kong
Italy
Novartis Investigative Site
Withdrawn
Bologna
Novartis Investigative Site
Active, not recruiting
Milano
Novartis Investigative Site
Active, not recruiting
Roma
Japan
Novartis Investigative Site
Withdrawn
Shinagawa Ku
Poland
Novartis Investigative Site
Active, not recruiting
Krakow
Novartis Investigative Site
Active, not recruiting
Warszawa
Novartis Investigative Site
Active, not recruiting
Wroclaw
Portugal
Novartis Investigative Site
Active, not recruiting
Lisboa
Novartis Investigative Site
Active, not recruiting
Porto
Republic of Korea
Novartis Investigative Site
Withdrawn
Seoul
Novartis Investigative Site
Completed
Seoul
Novartis Investigative Site
Active, not recruiting
Uijeongbu Si
Russian Federation
Novartis Investigative Site
Active, not recruiting
Moscow
Novartis Investigative Site
Active, not recruiting
Moscow
Novartis Investigative Site
Active, not recruiting
Saint Petersburg
Novartis Investigative Site
Active, not recruiting
Saint Petersburg
Spain
Novartis Investigative Site
Withdrawn
Las Palmas De Gran Canaria
Novartis Investigative Site
Recruiting
Madrid
Novartis Investigative Site
Recruiting
Sevilla
Novartis Investigative Site
Recruiting
Valencia
Taiwan
Novartis Investigative Site
Active, not recruiting
Changhua
Novartis Investigative Site
Recruiting
Taipei
Novartis Investigative Site
Active, not recruiting
Taoyuan
United Kingdom
Novartis Investigative Site
Recruiting
London
Novartis Investigative Site
Active, not recruiting
Oxford
Novartis Investigative Site
Recruiting
Wirral
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
+41613241111
Time Frame
Start Date: November 22, 2018
Estimated Completion Date: December 3, 2024
Participants
Target number of participants: 104
Treatments
Experimental: Asciminib 60mg QD + Imatinib 400mg QD
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
Experimental: Asciminib 40mg QD + Imatinib 400mg QD
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
Active Comparator: Imatinib 400mg QD
Imatinib 400 mg taken once daily
Active Comparator: Nilotinib 300mg BID
Nilotinib 300 mg taken twice daily
Experimental: Asciminib 80mg QD
Asciminib 80 mg taken once daily
Authors
B Douglas Smith, Richard A. Larson, Jorge Cortes, Michael A. Schuster, Carole Miller, Hagop Kantarjian
Sponsors
Leads: Novartis Pharmaceuticals

This content was sourced from clinicaltrials.gov

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