search
Back to results

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP) (ASC4START)

Primary Purpose

Philadelphia Chromosome-Positive Chronic Myeloid Leukemia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Asciminib
Nilotinib
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Philadelphia Chromosome-Positive Chronic Myeloid Leukemia focused on measuring Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Leukemia, ABL001, Phase 3, tyrosine kinase inhibitor, Chronic myelogenous leukemia (CML), chronic myeloid leukemia (CML), chronic myelocytic leukemia (CML), chronic granulocytic leukemia (CGL), cancer of the white blood cells, clonal bone marrow stem cell disorder proliferation of mature granulocytes, Chronic Myeloproliferative Disorders

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients with CML-CP within 3 months of diagnosis.
  2. Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome

    Documented chronic phase CML will meet all the below criteria Baccarani et al 2013:

    • < 15% blasts in peripheral blood and bone marrow,
    • < 30% blasts plus promyelocytes in peripheral blood and bone marrow,
    • < 20% basophils in the peripheral blood,
    • PLT count ≥ 100 x 10^9/L (≥ 100,000/mm3), except treatment induced thrombocytopenia
    • No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly.
  3. Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment.
  4. ECOG performance status of 0 or 1.
  5. Adequate end organ function as defined by:

    • Total bilirubin (TBL) < 3 x ULN; patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN,
    • 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. Patients 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 within normal limits or corrected to within normal limits with supplements prior to randomization.

      • CrCl as calculated using Cockcroft-Gault formula.

Exclusion Criteria:

  1. Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide.
  2. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required).
  3. Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following:

    • History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment.
    • 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 ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF.
    • 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.
  4. 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).
  5. History of significant congenital or acquired bleeding disorder unrelated to cancer.
  6. Major surgery within 4 weeks prior to study entry or patients who have not recovered from prior surgery.
  7. 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.
  8. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.
  9. History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.
  10. Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab/anti HBc) will be performed at screening. If anti-HBc is positive, HBV-DNA evaluation will be carried out at screening. A patient having positive HBV-DNA will not be enrolled in the study. Also, a patient with positive HBsAg will not be enrolled in the study. HCV Ab testing will also be performed at screening. For details on the criteria see Appendix 4.
  11. History of Human Immunodeficiency Virus (HIV) unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening.

Other protocol-defined Inclusion/exclusion criteria will apply.

Sites / Locations

  • Arizona Oncology Associates .Recruiting
  • Rocky Mountain Cancer Centers USORRecruiting
  • Regions Hospital Oncology Research ConsortiumRecruiting
  • Oncology Hematology Care Inc .Recruiting
  • Williamette Cancer CenterRecruiting
  • Texas Oncology P A .Recruiting
  • Texas Oncology PA BedfordRecruiting
  • Texas Oncology P A MidtownRecruiting
  • Lumi ResearchRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting
  • Novartis Investigative SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Asciminib

Nilotinib

Arm Description

Participants will receive asciminib 80 mg QD

Participants will receive nilotinib 300 mg BID

Outcomes

Primary Outcome Measures

Time to discontinuation of study treatment due to adverse event (TTDAE).
TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to adverse event (AE).

Secondary Outcome Measures

Percentage of participants with Major Molecular response (MMR) at scheduled data collection time points
MMR will be assessed using fusion gene of the BCR and ABL genes (BCR-ABL) transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MMR at each time point will be assessed.
Percentage of participants with Major Molecular response (MMR) by scheduled data collection time points
MMR will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MMR) at or before the specified visit will be calculated.
Percentage of participants with MR4.0 at scheduled data collection time points
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.0 at each time point will be assessed.
Percentage of participants with MR4.0 by scheduled data collection time points
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.0) at or before the specified visit will be calculated
Percentage of participants with MR4.5 at scheduled data collection time points
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.5 at each time point will be assessed.
Percentage of participants with MR4.5 by scheduled data collection time points
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.5) at or before the specified visit will be calculated
Percentage of participants with Complete Hematological response (CHR) at scheduled data collection time points
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants with CHR at each time point will be assessed.
Percentage of participants with Complete Hematological response (CHR) by scheduled data collection time points
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants who meet the criteria for having achieved the endpoint (CHR) at or before the specified visit will be calculated
Percentage of participants with BCR::ABL1 ratio ≤1% by Week 48 and Week 96.
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at or before the specified visit will be calculated
Duration of MMR
Duration of MMR is defined as the time between the date of the first documented achievement MMR and the earliest date of loss of MMR, treatment failure, progression to AP/BC, or CML-related death.
Duration of MR4.0
Duration of MR4.0 is defined as the time between the date of the first documented achievement MR4 and the earliest date of loss of MR4, treatment failure, progression to AP/BC, or CML-related death
Duration of MR4.5
Duration of MR4.5 is defined as the time between the date of the first documented achievement MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to AP/BC, or CML-related death.
Time to first MMR
Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR.
Time to first MR4.0
Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.
Time to first MR4.5
Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5.
Time to treatment failure (TTF).
TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: Treatment failure per European leukemia network (ELN) criteria, Confirmed loss of MMR (in 2 consecutive tests) at any time while on study treatment, Discontinuation from study treatment due to any reason
Event free survival (EFS)
EFS is defined as the time from the date of the first dose of study treatment to the earliest occurrence of treatment failure, confirmed lost of MMR, discontinuation due to AE, progression to AP/BC, and death from any cause.
Progression free survival (PFS).
PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.
Overall survival (OS).
OS is defined as the time from the date of randomization to the date of death from any cause.
Time to treatment discontinuation (TTD) due to selected reasons
TTD is the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to lack of efficacy, treatment failure, disease progression, suboptimal response or death
Change from baseline in overall scores and individual scales of the European organization for research and treatment of cancer - quality of life questionnaire (EORTC QLQ-C30)
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-C30. The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures based on the participant's experience over the past week. These include five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Change from baseline in overall scores and individual scales of the European organization for research and treatment of cancer CML module (EORTC QLQ-CML24)
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-CML24. The EORTC QLQ-CML24 assesses specific concepts relevant to the experience of patients with CML. The QLQ-CML24 has 24 items which assess symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life based on the participant's experience over the past week.

Full Information

First Posted
July 11, 2022
Last Updated
September 5, 2023
Sponsor
Novartis Pharmaceuticals
search

1. Study Identification

Unique Protocol Identification Number
NCT05456191
Brief Title
A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)
Acronym
ASC4START
Official Title
A Phase IIIb, Multi-center, Open-label, Randomized Study of Tolerability and Efficacy of Oral Asciminib Versus Nilotinib in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
February 15, 2027 (Anticipated)
Study Completion Date
March 15, 2027 (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
Yes

5. Study Description

Brief Summary
The study is designed to compare the tolerability of asciminib versus nilotinib for the treatment of newly diagnosed, previously untreated patients with Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP).
Detailed Description
This study is a phase IIIb, multi-center, open-label, randomized study of oral asciminib 80 mg once daily (QD) versus nilotinib 300 mg twice daily (BID) in adult patients with newly diagnosed Ph+ CML-CP. Participants will be randomized in the study in a 1:1 ratio to asciminib or nilotinib. No crossover of study treatment across arms will be allowed. Participants will be treated until unacceptable toxicity, disease progression and/or at the discretion of the investigator or the participants. A safety follow up visit/call will be performed approximately 30 days after end of treatment visit. Participants who discontinue study treatment prematurely due to any reason, will be followed up for survival and progression (to Accelerated Phase (AP)/Blast Crisis (BC)) up until end of study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Philadelphia Chromosome-Positive Chronic Myeloid Leukemia
Keywords
Chronic Myelogenous Leukemia, Chronic Myeloid Leukemia, Leukemia, ABL001, Phase 3, tyrosine kinase inhibitor, Chronic myelogenous leukemia (CML), chronic myeloid leukemia (CML), chronic myelocytic leukemia (CML), chronic granulocytic leukemia (CGL), cancer of the white blood cells, clonal bone marrow stem cell disorder proliferation of mature granulocytes, Chronic Myeloproliferative Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
550 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asciminib
Arm Type
Experimental
Arm Description
Participants will receive asciminib 80 mg QD
Arm Title
Nilotinib
Arm Type
Active Comparator
Arm Description
Participants will receive nilotinib 300 mg BID
Intervention Type
Drug
Intervention Name(s)
Asciminib
Other Intervention Name(s)
ABL001
Intervention Description
Asciminib 80 mg QD administered under fasting conditions.
Intervention Type
Drug
Intervention Name(s)
Nilotinib
Intervention Description
Nilotinib 300 mg BID administered under fasting conditions.
Primary Outcome Measure Information:
Title
Time to discontinuation of study treatment due to adverse event (TTDAE).
Description
TTDAE is defined as the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to adverse event (AE).
Time Frame
From date of first dose to date of treatment discontinuation due to AE, assessed up to 4.5 years
Secondary Outcome Measure Information:
Title
Percentage of participants with Major Molecular response (MMR) at scheduled data collection time points
Description
MMR will be assessed using fusion gene of the BCR and ABL genes (BCR-ABL) transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MMR at each time point will be assessed.
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with Major Molecular response (MMR) by scheduled data collection time points
Description
MMR will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MMR) at or before the specified visit will be calculated.
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with MR4.0 at scheduled data collection time points
Description
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.0 at each time point will be assessed.
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with MR4.0 by scheduled data collection time points
Description
MR4.0 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.0) at or before the specified visit will be calculated
Time Frame
Screening, week 4, week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years
Title
Percentage of participants with MR4.5 at scheduled data collection time points
Description
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants with MR4.5 at each time point will be assessed.
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with MR4.5 by scheduled data collection time points
Description
MR4.5 will be assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. The percentage of participants who meet the criteria for having achieved the endpoint (MR4.5) at or before the specified visit will be calculated
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with Complete Hematological response (CHR) at scheduled data collection time points
Description
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants with CHR at each time point will be assessed.
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with Complete Hematological response (CHR) by scheduled data collection time points
Description
Hematologic response will be assessed by complete blood count and physical examination at each visit. The percentage of participants who meet the criteria for having achieved the endpoint (CHR) at or before the specified visit will be calculated
Time Frame
Screening, Week 4, Week 12 and thereafter every 12 weeks until End of Treatment (EOT) and EOT, assessed up to approximately 4.5 years.
Title
Percentage of participants with BCR::ABL1 ratio ≤1% by Week 48 and Week 96.
Description
The percentage of participants who meet the criteria for having achieved BCR::ABL1 ratio ≤1% at or before the specified visit will be calculated
Time Frame
Week 48 and Week 96
Title
Duration of MMR
Description
Duration of MMR is defined as the time between the date of the first documented achievement MMR and the earliest date of loss of MMR, treatment failure, progression to AP/BC, or CML-related death.
Time Frame
From the date of the first documented molecular response at MMR level to the date of first documented loss of MMR or death due to any cause, whichever occurs first, assessed up to approximately 4.5 years.
Title
Duration of MR4.0
Description
Duration of MR4.0 is defined as the time between the date of the first documented achievement MR4 and the earliest date of loss of MR4, treatment failure, progression to AP/BC, or CML-related death
Time Frame
From the date of the first documented molecular response at MR4 level to the date of first documented loss of the response level or death due to any cause, whichever occurs first, assessed up to approximately 4.5 years.
Title
Duration of MR4.5
Description
Duration of MR4.5 is defined as the time between the date of the first documented achievement MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to AP/BC, or CML-related death.
Time Frame
From the date of the first documented molecular response at MR4.5 level to the date of first documented loss of the response level or death due to any cause, whichever occurs first, assessed up to approximately 4.5 years.
Title
Time to first MMR
Description
Time to first MMR is defined as the time from the date of randomization to the date of the first documented occurrence of MMR.
Time Frame
From the date of randomization to the date of the first MMR, assessed up to approximately 4.5 years.
Title
Time to first MR4.0
Description
Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.
Time Frame
From the date of randomization to the date of the first MR4, assessed up to approximately 4.5 years.
Title
Time to first MR4.5
Description
Time to first MR4.5 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.5.
Time Frame
From the date of randomization to the date of the first MR4.5, assessed up to approximately 4.5 years.
Title
Time to treatment failure (TTF).
Description
TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: Treatment failure per European leukemia network (ELN) criteria, Confirmed loss of MMR (in 2 consecutive tests) at any time while on study treatment, Discontinuation from study treatment due to any reason
Time Frame
Up to approximately 4.5 years.
Title
Event free survival (EFS)
Description
EFS is defined as the time from the date of the first dose of study treatment to the earliest occurrence of treatment failure, confirmed lost of MMR, discontinuation due to AE, progression to AP/BC, and death from any cause.
Time Frame
Up to approximately 4.5 years.
Title
Progression free survival (PFS).
Description
PFS is defined as the time from the date of randomization to the earliest occurrence of progression to AP/BC or death from any cause.
Time Frame
Up to approximately 4.5 years.
Title
Overall survival (OS).
Description
OS is defined as the time from the date of randomization to the date of death from any cause.
Time Frame
Up to approximately 4.5 years.
Title
Time to treatment discontinuation (TTD) due to selected reasons
Description
TTD is the time from the date of first dose of study treatment to the date of discontinuation of study treatment due to lack of efficacy, treatment failure, disease progression, suboptimal response or death
Time Frame
Up to approximately 4.5 years
Title
Change from baseline in overall scores and individual scales of the European organization for research and treatment of cancer - quality of life questionnaire (EORTC QLQ-C30)
Description
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-C30. The EORTC QLQ-C30 contains 30 items and is composed of both multi-item scales and single-item measures based on the participant's experience over the past week. These include five functional scales (physical, role, emotional, cognitive and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/QoL scale.
Time Frame
Baseline, every 4 weeks from Week 4 to Week 12, after Week 24, Week 48, Week 96, EOT and every 4 weeks until 12 weeks after EOT, assessed up to approximately 4.5 years.
Title
Change from baseline in overall scores and individual scales of the European organization for research and treatment of cancer CML module (EORTC QLQ-CML24)
Description
Change from baseline in Overall Scores and individual domains of the EORTC QLQ-CML24. The EORTC QLQ-CML24 assesses specific concepts relevant to the experience of patients with CML. The QLQ-CML24 has 24 items which assess symptom burden, impact on daily life and on worry/mood, body image problems, and satisfaction with care and with social life based on the participant's experience over the past week.
Time Frame
Baseline, every 4 weeks from Week 4 to Week 12, after Week 24, Week 48, Week 96, EOT and every 4 weeks until 12 weeks after EOT, assessed up to approximately 4,5 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with CML-CP within 3 months of diagnosis. Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of the Philadelphia chromosome Documented chronic phase CML will meet all the below criteria Baccarani et al 2013: < 15% blasts in peripheral blood and bone marrow, < 30% blasts plus promyelocytes in peripheral blood and bone marrow, < 20% basophils in the peripheral blood, PLT count ≥ 100 x 10^9/L (≥ 100,000/mm3), except treatment induced thrombocytopenia No evidence of extramedullary leukemic involvement, with the exception of hepatosplenomegaly. Evidence of typical BCR::ABL1 transcript [e14a2 and/or e13a2] which is amenable to standardized RQ-PCR quantification by the central laboratory assessment. ECOG performance status of 0 or 1. Adequate end organ function as defined by: Total bilirubin (TBL) < 3 x ULN; patients with Gilbert's syndrome may only be included if TBL ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN, 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. Patients 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 within normal limits or corrected to within normal limits with supplements prior to randomization. CrCl as calculated using Cockcroft-Gault formula. Exclusion Criteria: Previous treatment of CML with any other anticancer agents including chemotherapy and/or biologic agents or prior stem cell transplant, with the exception of hydroxyurea and/or anagrelide. Known cytopathologically confirmed CNS infiltration (in absence of suspicion of CNS involvement, lumbar puncture not required). Impaired cardiac function or cardiac repolarization abnormality including but not limited to any one of the following: History of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG) within 6 months prior to starting study treatment. 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 ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula). If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTcF. 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. 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). History of significant congenital or acquired bleeding disorder unrelated to cancer. Major surgery within 4 weeks prior to study entry or patients who have not recovered from prior surgery. 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. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis. History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease. Known history of chronic Hepatitis B (HBV), or chronic Hepatitis C (HCV) infection. Testing for Hepatitis B surface antigen (HBs Ag) and Hepatitis B core antibody (HBc Ab/anti HBc) will be performed at screening. If anti-HBc is positive, HBV-DNA evaluation will be carried out at screening. A patient having positive HBV-DNA will not be enrolled in the study. Also, a patient with positive HBsAg will not be enrolled in the study. HCV Ab testing will also be performed at screening. For details on the criteria see Appendix 4. History of Human Immunodeficiency Virus (HIV) unless well-controlled on a stable dose of anti-retroviral therapy at the time of screening. Other protocol-defined Inclusion/exclusion criteria will 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
Arizona Oncology Associates .
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Langerak
Facility Name
Rocky Mountain Cancer Centers USOR
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Dimopoulos
Phone
303-385-2000
Email
Lee.Dimopoulos@usoncology.com
First Name & Middle Initial & Last Name & Degree
David J Andorsky
Facility Name
Regions Hospital Oncology Research Consortium
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Reardon
Email
patrick.reardon@parknicollet.com
First Name & Middle Initial & Last Name & Degree
Yan Ji
Facility Name
Oncology Hematology Care Inc .
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zachary Beck
Email
zach.beck@usoncology.com
First Name & Middle Initial & Last Name & Degree
Kruti Patel
Facility Name
Williamette Cancer Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Chavez
Email
alex.chavez@usoncology.com
First Name & Middle Initial & Last Name & Degree
Luke Fletcher
Facility Name
Texas Oncology P A .
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Butterworth
Email
ginger.butterworth@usoncology.com
First Name & Middle Initial & Last Name & Degree
Andrew Jackson
Facility Name
Texas Oncology PA Bedford
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Illum
Facility Name
Texas Oncology P A Midtown
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reba Wise
Phone
512-421-4100
Email
reba.wise@usoncology.com
First Name & Middle Initial & Last Name & Degree
Jason M Melear
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
Whitney Nwole
Phone
281-809-0676
Email
wnwole@lumiresearch.com
First Name & Middle Initial & Last Name & Degree
Saleha Sajid
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caba
State/Province
Buenos Aires
ZIP/Postal Code
C1221ADH
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos aires
ZIP/Postal Code
C1039AAC
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1114AAN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1425AUM
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plovdiv
ZIP/Postal Code
4002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1413
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Brno Bohunice
State/Province
Czech Republic
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 2
State/Province
Czech Republic
ZIP/Postal Code
128 20
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Plzen-Bory
ZIP/Postal Code
30599
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Praha 10
ZIP/Postal Code
100 34
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Caen Cedex
ZIP/Postal Code
14033
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Lyon
ZIP/Postal Code
69373
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marseille
ZIP/Postal Code
13273
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nantes Cedex 1
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Nice
ZIP/Postal Code
06202
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paris 10
ZIP/Postal Code
75475
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Strasbourg
ZIP/Postal Code
67200
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Vandoeuvre les Nancy cedex
ZIP/Postal Code
54511
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
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
State/Province
Bayern
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Velbert
State/Province
North Rhine-Westphalia
ZIP/Postal Code
42551
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Augsburg
ZIP/Postal Code
86179
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bayreuth
ZIP/Postal Code
95445
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53105
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bremen
ZIP/Postal Code
28177
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Halle S
ZIP/Postal Code
06120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30161
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Jena
ZIP/Postal Code
07740
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80377
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ioannina
State/Province
GR
ZIP/Postal Code
455 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Larissa
State/Province
GR
ZIP/Postal Code
411 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
570 10
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Patras
ZIP/Postal Code
265 00
Country
Greece
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Eger
ZIP/Postal Code
3300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Ahmedabad
State/Province
Gujrat
ZIP/Postal Code
380009
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Varanasi
State/Province
Uttar Pradesh
ZIP/Postal Code
221010
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Rishikesh
State/Province
Uttarakhand
ZIP/Postal Code
249203
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
New Delhi
ZIP/Postal Code
110029
Country
India
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Amman
ZIP/Postal Code
11941
Country
Jordan
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bundang Gu
State/Province
Gyeonggi Do
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Uijeongbu si
State/Province
Gyeonggi Do
ZIP/Postal Code
11759
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Alor Setar
State/Province
Kedah
ZIP/Postal Code
05460
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Petaling Jaya
State/Province
Selangor Darul Ehsan
ZIP/Postal Code
46150
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Dordrecht
ZIP/Postal Code
3318AT
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Muscat
ZIP/Postal Code
123
Country
Oman
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
State/Province
District 2
ZIP/Postal Code
022328
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Tg Mures
State/Province
Mures
ZIP/Postal Code
540136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
030 171
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
021494
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Cluj-Napoca
ZIP/Postal Code
400124
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Craiova
ZIP/Postal Code
200136
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Timisoara
ZIP/Postal Code
300079
Country
Romania
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
119228
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Singapore
ZIP/Postal Code
S308433
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Kosice
State/Province
Slovak Republic
ZIP/Postal Code
040 66
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Bratislava
ZIP/Postal Code
85107
Country
Slovakia
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Pretoria
ZIP/Postal Code
0044
Country
South Africa
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Genève
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Truro
State/Province
Cornwall
ZIP/Postal Code
TR1 3LJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Novartis Investigative Site
City
Gloucester
ZIP/Postal Code
GL1 3NN
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

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 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

Learn more about this trial

A Study to Investigate Tolerability and Efficacy of Asciminib (Oral) Versus Nilotinib (Oral) in Adult Participants (≥18 Years of Age) With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase (Ph+ CML-CP)

We'll reach out to this number within 24 hrs