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Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

Primary Purpose

CML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Asciminib add-on
Imatinib
Nilotinib
Asciminib single agent
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CML focused on measuring CML, Chronic Myelogenous Leukemia, leukemia, myeloid chronic, Hematologic Diseases, Asciminib, ABL001, Imatinib, Nilotinib, deep molecular response, DMR, Ph+ CML, chronic phase, cancer of the white blood cells, tyrosine kinase inhibitor, leukemia, myeloid, leukemia, CML without Ph+

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male or female patients ≥ 18 years of age with a confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase (CML-CP).
  2. 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.

  3. 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
  4. 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
  5. 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.

Key Exclusion Criteria:

  1. Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment.
  2. Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC).
  3. Previous treatment with any tyrosine kinese inhibitors (TKIs) other than imatinib.
  4. History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as:

    • History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization
    • Concomitant clinically significant arrhythmias
    • Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization
    • 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
      • Concomitant medications with a "known" risk of Torsades de Pointes
      • inability to determine the QTcF interval
  5. 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 clinically significant hyperlipidemia and high serum amylase)
  6. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis; on-going acute liver disease or history of chronic liver disease
  7. History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.

Other protocol defined inclusion/exclusion may apply.

Sites / Locations

  • Georgia Regents University
  • University of ChicagoRecruiting
  • Sidney Kimmel Comprehensive Cancer Center
  • Saint Agnes Healthcare Cancer Institute
  • SUNY Stony Brook Medical Oncology Hematology/Oncology
  • Uni of TX MD Anderson Cancer Cntr
  • Lumi ResearchRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Asciminib 60mg QD + Imatinib 400mg QD

Asciminib 40mg QD + Imatinib 400mg QD

Imatinib 400mg QD

Nilotinib 300mg BID

Asciminib 80mg QD

Arm Description

Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily

Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily

Imatinib 400 mg taken once daily

Nilotinib 300 mg taken twice daily

Asciminib 80 mg taken once daily

Outcomes

Primary Outcome Measures

Molecular Response (MR)^4.5 rate between asciminib+imatinib and imatinib alone
Proportion of subjects still treated with the randomized treatment at 48 weeks and are in MR4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all subjects randomized to the respective treatment arm.

Secondary Outcome Measures

MR^4.5 rate at 48 weeks
Difference in the proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks between asciminib+imatinib and nilotinib
Difference in rate of MR^4.5 at 48 weeks
Difference in the proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks between asciminib+imatinib and nilotinib
Rate of MR^4.5 at 96 weeks
Proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 96 weeks
Rate of MR^4.5 by 48 and 96 weeks
Best observed rate of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) under randomized treatment up to the specific time point
Sustained MR^4.5 from 48 weeks until 96 weeks
Percentage of participants who are in MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 96 weeks and who have no loss of MR^4.5.
Time to MR^4.5
Time to MR^4.5 is the time from randomization to first MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) computed only for subjects who achieved MR^4.5
Duration of MR^4.5
Time from first MR^4.5 until loss of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%).
Incidence and severity of adverse events, changes in laboratory values, clinically notable ECG abnormalities and vital signs
To characterize the safety and tolerability profile of asciminib 60 mg or 40 mg + imatinib vs continued imatinib or switch to nilotinib or asciminib 80mg QD
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmax
The maximum (peak) observed drug concentration after dose administration
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Tmax
The time to reach maximum (peak) drug concentration after dose administration
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmin
Minimum drug concentration
Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUClast
The AUC from time zero to the last measurable concentration sampling time (Tlast)
Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUCtau
The AUC calculated to the end of a dosing interval (tau) at steady-state
MR^4.5 rate at 48 weeks
The proportion of subjects on asciminib 80mg QD with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks
Time to MR^4.5
For subjects on asciminib 80mg QD: Time to MR^4.5 is the time from randomization to first MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) computed only for subjects who achieved MR^4.5
Duration of MR^4.5
Time from first MR^4.5 until loss of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) for subjects on asciminib 80mg QD
Pharmacokinetic profile of asciminib 80mg QD - Cmax
The maximum (peak) observed drug concentration after dose administration
Pharmacokinetic profile of asciminib 80mg QD - Tmax
The time to reach maximum (peak) drug concentration after dose administration
Pharmacokinetic profile of asciminib 80mg QD - Cmin
Minimum drug concentration
Pharmacokinetic profile of asciminib 80mg QD - AUClast
The AUC from time zero to the last measurable concentration sampling time (Tlast)
Pharmacokinetic profile of asciminib 80mg QD - AUCtau
The AUC calculated to the end of a dosing interval (tau) at steady-state

Full Information

First Posted
June 15, 2018
Last Updated
October 12, 2023
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT03578367
Brief Title
Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2018 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
November 21, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)
Detailed Description
The study is a Phase 2, multi-center, open-label, randomized study of asciminib in two different doses (40 mg or 60 mg) in combination with imatinib 400 mg versus continued imatinib versus switch to nilotinib, versus asciminib 80mg single agent in subjects with chronic myeloid leukemia in chronic phase (CML-CP) who have been previously treated with imatinib first line therapy for at least one year and have not achieved deep molecular response (DMR). Eighty-four eligible subjects were randomized 1:1:1:1 to receive asciminib 60 mg once daily (QD) as add-on therapy to imatinib 400 mg QD, or 40 mg QD as add-on therapy to imatinib 400 mg QD, or to continue imatinib 400 mg QD, or to switch to nilotinib 300 mg twice a day (BID). The asciminib single agent cohort will be conducted as an open label cohort. Approximately 20 eligible subjects will be enrolled to receive asciminib 80 mg QD. An interim analysis was performed to gain an early insight into the safety and efficacy of the asciminib add-on combination. The interim analysis was planned to be performed when at least 40 (50%) patients have been randomized and have been followed for their 24 weeks visit assessment or have discontinued treatment. The interim analysis cut-off was on 22-July-2020. No change in study conduct were performed based on the benefit/risk balance. This amendment aims to add an asciminib single agent cohort to assess whether asciminib single agent at the recommended dose of 80mg QD leads to similar efficacy and safety as observed in the add-on arms of asciminib and imatinib. This additional cohort will help to evaluate if the combination of asciminib with imatinib is needed to increase the likelihood of achieving DMR, or if this can be achieved by asciminib alone. The primary analysis cut-off was on 10-Jan-2022. Eighty-four patients have been randomized in the study. Subjects on the imatinib continuation arm who had not achieved MR4.5 at 48 weeks were allowed to cross-over (CO) to receive the add-on treatment within 4 weeks after week 48 visit. to receive the asciminib 60 mg combination add-on treatment, as this dose provided higher exposure. The cross-over is at the discretion of the investigator and the patient. Apart from a polymerase chain reaction (PCR) result of below MR4.5 at Week 48 visit, there are no other entry criteria for the cross-over part. Subjects on nilotinib are not allowed to cross- over to receive the add-on treatment. Subjects on the study will continue on the allocated treatment until treatment failure, intolerability, or for up to 96 weeks (in arms 1 to 4) / or 48 weeks (in asciminib single agent cohort) after the last randomized subject received the first dose of treatment. After the last dose received, every subject will be followed up for safety for 30 days.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CML, Chronic Myelogenous Leukemia, Leukemia, Myeloid Chronic, Hematologic Diseases
Keywords
CML, Chronic Myelogenous Leukemia, leukemia, myeloid chronic, Hematologic Diseases, Asciminib, ABL001, Imatinib, Nilotinib, deep molecular response, DMR, Ph+ CML, chronic phase, cancer of the white blood cells, tyrosine kinase inhibitor, leukemia, myeloid, leukemia, CML without Ph+

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Treatment arms 1 - 4 randomized; New Treatment arm 5 (asciminib single agent cohort) not randomized
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asciminib 60mg QD + Imatinib 400mg QD
Arm Type
Experimental
Arm Description
Asciminib 60 mg taken once daily in combination with Imatinib 400 mg taken once daily
Arm Title
Asciminib 40mg QD + Imatinib 400mg QD
Arm Type
Experimental
Arm Description
Asciminib 40 mg taken once daily in combination with Imatinib 400 mg taken once daily
Arm Title
Imatinib 400mg QD
Arm Type
Active Comparator
Arm Description
Imatinib 400 mg taken once daily
Arm Title
Nilotinib 300mg BID
Arm Type
Active Comparator
Arm Description
Nilotinib 300 mg taken twice daily
Arm Title
Asciminib 80mg QD
Arm Type
Experimental
Arm Description
Asciminib 80 mg taken once daily
Intervention Type
Drug
Intervention Name(s)
Asciminib add-on
Other Intervention Name(s)
ABL001 (asciminib)
Intervention Description
Asciminib 60 mg or 40 mg taken orally once daily.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
STI571
Intervention Description
Imatinib 400 mg taken orally once daily
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Other Intervention Name(s)
AMN107
Intervention Description
Nilotinib 300 mg taken orally twice daily (total daily dose of 600 mg)
Intervention Type
Drug
Intervention Name(s)
Asciminib single agent
Other Intervention Name(s)
ABL001 (asciminib)
Intervention Description
Asciminib 80 mg taken orally once daily
Primary Outcome Measure Information:
Title
Molecular Response (MR)^4.5 rate between asciminib+imatinib and imatinib alone
Description
Proportion of subjects still treated with the randomized treatment at 48 weeks and are in MR4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks (± assessment window), among all subjects randomized to the respective treatment arm.
Time Frame
at 48 weeks
Secondary Outcome Measure Information:
Title
MR^4.5 rate at 48 weeks
Description
Difference in the proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks between asciminib+imatinib and nilotinib
Time Frame
at 48 weeks
Title
Difference in rate of MR^4.5 at 48 weeks
Description
Difference in the proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks between asciminib+imatinib and nilotinib
Time Frame
at 48 weeks
Title
Rate of MR^4.5 at 96 weeks
Description
Proportion of subjects with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 96 weeks
Time Frame
at 96 weeks
Title
Rate of MR^4.5 by 48 and 96 weeks
Description
Best observed rate of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) under randomized treatment up to the specific time point
Time Frame
by 48 weeks and 96 weeks
Title
Sustained MR^4.5 from 48 weeks until 96 weeks
Description
Percentage of participants who are in MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 96 weeks and who have no loss of MR^4.5.
Time Frame
at 96 weeks
Title
Time to MR^4.5
Description
Time to MR^4.5 is the time from randomization to first MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) computed only for subjects who achieved MR^4.5
Time Frame
up to 96 weeks
Title
Duration of MR^4.5
Description
Time from first MR^4.5 until loss of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%).
Time Frame
end of treatment
Title
Incidence and severity of adverse events, changes in laboratory values, clinically notable ECG abnormalities and vital signs
Description
To characterize the safety and tolerability profile of asciminib 60 mg or 40 mg + imatinib vs continued imatinib or switch to nilotinib or asciminib 80mg QD
Time Frame
end of study
Title
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmax
Description
The maximum (peak) observed drug concentration after dose administration
Time Frame
up to 96 weeks
Title
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Tmax
Description
The time to reach maximum (peak) drug concentration after dose administration
Time Frame
up to 96 weeks
Title
Pharmacokinetic profile of asciminib and imatinib when administered in combination - Cmin
Description
Minimum drug concentration
Time Frame
up to 96 weeks
Title
Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUClast
Description
The AUC from time zero to the last measurable concentration sampling time (Tlast)
Time Frame
up to 96 weeks
Title
Pharmacokinetic profile of asciminib and imatinib when administered in combination - AUCtau
Description
The AUC calculated to the end of a dosing interval (tau) at steady-state
Time Frame
up to 96 weeks
Title
MR^4.5 rate at 48 weeks
Description
The proportion of subjects on asciminib 80mg QD with MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) at 48 weeks
Time Frame
at 48 weeks
Title
Time to MR^4.5
Description
For subjects on asciminib 80mg QD: Time to MR^4.5 is the time from randomization to first MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) computed only for subjects who achieved MR^4.5
Time Frame
up to 48 weeks
Title
Duration of MR^4.5
Description
Time from first MR^4.5 until loss of MR^4.5 (BCR-ABL1 ratio of ≤ 0.0032%) for subjects on asciminib 80mg QD
Time Frame
end of treatment
Title
Pharmacokinetic profile of asciminib 80mg QD - Cmax
Description
The maximum (peak) observed drug concentration after dose administration
Time Frame
up to 48 weeks
Title
Pharmacokinetic profile of asciminib 80mg QD - Tmax
Description
The time to reach maximum (peak) drug concentration after dose administration
Time Frame
up to 48 weeks
Title
Pharmacokinetic profile of asciminib 80mg QD - Cmin
Description
Minimum drug concentration
Time Frame
up to 48 weeks
Title
Pharmacokinetic profile of asciminib 80mg QD - AUClast
Description
The AUC from time zero to the last measurable concentration sampling time (Tlast)
Time Frame
up to 48 weeks
Title
Pharmacokinetic profile of asciminib 80mg QD - AUCtau
Description
The AUC calculated to the end of a dosing interval (tau) at steady-state
Time Frame
up to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Key Exclusion Criteria: Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment. Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC). Previous treatment with any tyrosine kinese inhibitors (TKIs) other than imatinib. History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as: History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization Concomitant clinically significant arrhythmias Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization 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 Concomitant medications with a "known" risk of Torsades de Pointes inability to determine the QTcF interval 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 clinically significant hyperlipidemia and high serum amylase) History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis; on-going acute liver disease or history of chronic liver disease History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively. Other protocol defined inclusion/exclusion may apply.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
1-888-669-6682
Email
novartis.email@novartis.com
First Name & Middle Initial & Last Name or Official Title & Degree
Novartis Pharmaceuticals
Phone
+41613241111
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Georgia Regents University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Completed
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belen M. Aguado
Phone
773-702-8582
Email
bmartinezcaroa@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Richard A. Larson
Facility Name
Sidney Kimmel Comprehensive Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Completed
Facility Name
Saint Agnes Healthcare Cancer Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Withdrawn
Facility Name
SUNY Stony Brook Medical Oncology Hematology/Oncology
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-8174
Country
United States
Individual Site Status
Withdrawn
Facility Name
Uni of TX MD Anderson Cancer Cntr
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Withdrawn
Facility Name
Lumi Research
City
Kingwood
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhavin Shah
Phone
281-809-0676
Email
bhavin@lumiresearch.com
First Name & Middle Initial & Last Name & Degree
Saleha Sajid
Facility Name
Novartis Investigative Site
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
8036
Country
Austria
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Wien
ZIP/Postal Code
1140
Country
Austria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Temuco
State/Province
Araucania
ZIP/Postal Code
4800827
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Vina del Mar
State/Province
Valparaiso
ZIP/Postal Code
2540364
Country
Chile
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Brno - Bohunice
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Mannheim
State/Province
Baden Wuerttemberg
ZIP/Postal Code
68305
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Hong Kong
Country
Hong Kong
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Bologna
State/Province
BO
ZIP/Postal Code
40138
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Roma
State/Province
RM
ZIP/Postal Code
00161
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Shinagawa ku
State/Province
Tokyo
ZIP/Postal Code
141 8625
Country
Japan
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Uijeongbu si
State/Province
Gyeonggi Do
ZIP/Postal Code
11759
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Seocho Gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Krakow
ZIP/Postal Code
31 531
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
02 776
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Wroclaw
ZIP/Postal Code
50 367
Country
Poland
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1099 023
Country
Portugal
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125167
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
191024
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Saint Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Novartis Investigative Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Changhua
ZIP/Postal Code
50006
Country
Taiwan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Completed
Facility Name
Novartis Investigative Site
City
Wirral
State/Province
Merseyside
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Oxford
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 expert 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 is currently available according to the process described on www.clinicalstudydatarequest.com.
IPD Sharing URL
https://www.clinicalstudydatarequest.com

Learn more about this trial

Study of Efficacy and Safety of Asciminib in Combination With Imatinib in Patients With Chronic Myeloid Leukemia in Chronic Phase (CML-CP)

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