A Study of Oral Asciminib Versus Other TKIs in Adult Patients With Newly Diagnosed Ph+ CML-CP

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04971226
Collaborator
(none)
402
129
2
85.6
3.1
0

Study Details

Study Description

Brief Summary

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

Detailed Description

This study is a phase III, multi-center, open-label, randomized study of oral asciminib 80 mg QD versus Investigator selected TKI (imatinib, nilotinib, dasatinib, or bosutinib) in adult patients with newly diagnosed Ph+ CML-CP. All comparator TKIs will be made available, unless not permitted by local regulations or local Health Authority, or not approved for the treatment of CML in the country.

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

Approximately 402 patients will be randomized in a 1:1 ratio to asciminib and Investigator selected TKI.

Randomization will be stratified based on the following two stratification factors:
  • ELTS score (low versus intermediate versus high)

  • Pre-randomization selected TKI (imatinib versus 2G TKI (nilotinib or dasatinib or bosutinib)).

Prior to randomization, the Investigator, in consultation with the patient, considering the current treatment paradigm and patient characteristics and comorbidities, will make a selection of preference for imatinib or 2G TKI (nilotinib or dasatinib or bosutinib) if the patient is randomized to the comparator arm.

To further ensure that the distribution of patients, between imatinib and 2G TKIs (nilotinib or dasatinib or bosutinib), in the Investigator selected TKI arm is reflective of the use of these agents in clinical practice, the enrollment into the strata of imatinib versus 2G TKI (nilotinib or dasatinib or bosutinib) based on the pre-randomization selection of TKI will be managed by Interactive Response Technology to be approximately 50% versus 50%.

Treatment arms: The study will have 2 treatment arms:
  • Arm 1: asciminib 80 mg QD under fasting conditions

  • Arm 2: Investigator selected TKI that will include one of the below treatments:

  • Imatinib 400 mg QD administered with food

  • Nilotinib 300 mg BID administered under fasting conditions

  • Dasatinib 100 mg QD administered with or without meal

  • Bosutinib 400 mg QD administered with food.

No crossover of study treatment across arms and no change of study treatment within the Investigator selected TKI will be allowed.

Duration of Study treatment: Patients on the study will continue to receive the assigned treatment until the End of Study, or until premature discontinuation due to treatment failure, disease progression or intolerance or due to Investigator or participant decision.

Duration of study: The End of Study will occur 5 years from the last patient first treatment in the study. Patients who discontinue study treatment prematurely due to any reason, will be followed up for survival and progression (to AP/BC) until the End of Study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
402 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase III, Multi-center, Open-label, Randomized Study of Oral Asciminib Versus Investigator Selected TKI in Patients With Newly Diagnosed Philadelphia Chromosome Positive Chronic Myelogenous Leukemia in Chronic Phase
Actual Study Start Date :
Oct 6, 2021
Anticipated Primary Completion Date :
Sep 27, 2024
Anticipated Study Completion Date :
Nov 24, 2028

Arms and Interventions

Arm Intervention/Treatment
Experimental: Asciminib

Patients will take asciminib 80 mg QD under fasting conditions on ongoing basis; Patients will be randomized 1:1 asciminib versus Investigator selected TKIs

Drug: Asciminib
Comes in 40 mg tablets and taken orally
Other Names:
  • ABL001
  • Active Comparator: Investigator selected TKIs

    Patients will take on ongoing basis the Investigator selected TKIs that will include one of the below treatments: Imatinib 400 mg QD administered with food Nilotinib 300 mg BID administered under fasting conditions Dasatinib 100 mg QD administered with or without a meal Bosotunib 400 mg QD administered with food

    Drug: Imatinib
    Comes in 100 mg and 400 mg tablets and taken orally
    Other Names:
  • STI571
  • Drug: Nilotinib
    Comes in 150 mg capsules and taken orally
    Other Names:
  • AMN107
  • Drug: Bosutinib
    Comes in 100 mg and 400 mg tablets and taken orally

    Drug: Dasatinib
    Comes in 70 mg and 100 mg tablets and taken orally

    Outcome Measures

    Primary Outcome Measures

    1. Major Molecular Response (MMR) at week 48 [at 48 weeks (48 weeks after last patient first dose)]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

    Secondary Outcome Measures

    1. Major Molecular response at week 96 [at 96 weeks (96 weeks after last patient first dose)]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

    2. Time to discontinuation of study treatment due to Adverse Events (TTDAE) [96 weeks after last patient first dose]

      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). For patients ongoing without study treatment discontinuation, on or prior to the analysis cut-off date, the time will be censored at the at the analysis cut-off date.

    3. Major Molecular response at scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

    4. Major Molecular response by scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MMR is defined as a ratio BCR-ABL/ABL ≤0.1% on the international scale (ie, at least 3 log reduction from a standardized baseline value).

    5. MR4.0 at scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).

    6. MR4.5 at all scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).

    7. MR4.0 by scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.0 is defined as a ratio BCR-ABL/ABL ≤0.01% on the international scale (ie, at least 4 log reduction from a standardized baseline value).

    8. MR4.5 by all scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction. MR4.5 is defined as a ratio BCR-ABL/ABL ≤0.0032% on the international scale (ie, at least 4.5 log reduction from a standardized baseline value).

    9. Complete Hematological response (CHR) at all scheduled data collection time points [Planned total follow-up duration of 5 years]

      Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count < 10 x 10^9/L PLT count < 450 x 10^9/L Basophils < 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes < 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver

    10. Complete Hematological response (CHR) by all scheduled data collection time points [Planned total follow-up duration of 5 years]

      Hematologic response will be assessed by CBC and physical examination at each visit. Complete Hematological Response (CHR) will be defined as all of the following present for ≥ 4 weeks: white blood cell(s) (WBC) count < 10 x 10^9/L PLT count < 450 x 10^9/L Basophils < 5% No blasts and promyelocytes in peripheral blood Myelocytes + metamyelocytes < 5% in peripheral blood No evidence of extramedullary disease, including spleen and liver

    11. Complete Cytogenic response (CCyR) at Week 48 & Week 96 [at 48 weeks and at 96 weeks (48 weeks and 96 weeks after last patient first dose)]

      The CCyR response status will be based on bone marrow assessment, in any patients who have this done due to a clinical indication

    12. Complete Cytogenic response (CCyR) by Week 48 & Week 96 [at 48 weeks and at 96 weeks (48 weeks and 96 weeks after last patient first dose)]

      The CCyR response status will be based on bone marrow assessment, in any patients who have this done due to a clinical indication

    13. Duration of MMR [Planned total follow-up duration of 5 years]

      Duration of MMR is defined as the time between the date of the first documented achievement of MMR and the earliest date of loss of MMR, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

    14. Duration of MR4.0 [Planned total follow-up duration of 5 years]

      Duration of MR4.0 is defined as the time between the date of the first documented achievement of MR4.0 and the earliest date of loss of MR4.0, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

    15. Duration of MR4.5 [Planned total follow-up duration of 5 years]

      Duration of MR4.5 is defined as the time between the date of the first documented achievement of MR4.5 and the earliest date of loss of MR4.5, treatment failure, progression to Accelerated Phase/Blast Crisis, or CML-related death

    16. Time to first MMR [Planned total follow-up duration of 5 years]

      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 will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MMR.

    17. Time to first MR4.0 [Planned total follow-up duration of 5 years]

      Time to first MR4.0 is defined as the time from the date of randomization to the date of the first documented occurrence of MR4.0. Time will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.0.

    18. Time to first MR4.5 [Planned total follow-up duration of 5 years]

      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 will be censored at the last molecular assessment date while on treatment, or the End Of Treatment (whichever comes first) for patients who have not experienced MR4.5.

    19. BCR-ABL1≤1% at scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.

    20. BCR-ABL1≤1% by scheduled data collection time points [Planned total follow-up duration of 5 years]

      Molecular response is assessed using BCR-ABL transcript levels measured by realtime quantitative polymerase chain reaction.

    21. Time to treatment failure (TTF) [Planned total follow-up duration of 5 years]

      TTF is defined as the time from date of randomization to the first/earliest documented date of any of the following events: treatment failure as per ELN, Confirmed loss of MMR while on study treatment, discontinuation from study treatment due to any reason For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the last study assessment date while on treatment, or the EOT (whichever comes first) .

    22. Failure Free Survival (FFS) [Planned total follow-up duration of 5 years]

      FFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure per ELN, confirmed loss of MMR, progression to AP/BC, death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

    23. Event Free Survival (EFS) [Planned total follow-up duration of 5 years]

      EFS is defined as the time from the date of randomization to the earliest occurrence of the following events: treatment failure as per ELN, confirmed loss of MMR ,discontinuation of study treatment due to AE, progression to AP/BC, death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

    24. Progression Free Survival (PFS) [Planned total follow-up duration of 5 years]

      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. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last study treatment assessment or last post-treatment follow-up.

    25. Overall Survival (OS) [Planned total follow-up duration of 5 years]

      OS is defined as the time from the date of randomization to the date of death from any cause. For patients that have not experienced an event prior to or at the analysis cut-off date, the time will be censored at the date of last contact before the cut-off date.

    26. Trough plasma concentrations. [48 weeks after last patient first dose]

      Trough plasma concentration will measure the concentration of asciminib in the blood immediately before the next dose is administered.

    27. Pharmacokinetics (PK) of Asciminib: Cmax [48 weeks after last patient first dose]

      Cmax is the maximum serum concentration of asciminib during a dosing interval (mass x volume-1).

    28. PK of Asciminib: Tmax [48 weeks after last patient first dose]

      Tmax is the time to reach maximum (peak) plasma drug concentration after dose administration (time)

    29. PK of Asciminib: AUCtau and AUClast [48 weeks after last patient first dose]

      AUCtau is the area under the plasma concentration-time curve over the dosing interval. AUClast is the area under the plasma concentration-time curve from time zero (time of dose administration) to time of last measurable concentration (mass x time x volume-1)

    30. PK of Asciminib: CL/F [48 weeks after last patient first dose]

      CL/F is the apparent total body clearance of asciminib from plasma after oral administration (volume x time-1).

    31. Change from baseline in overall scores and individual scales of the EORTC QLQ-C30 [baseline, 48 weeks after last patient first dose, 96 weeks after last patient first dose]

      The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-30) consists of functioning scales, symptoms' scales, single-item scales and the global health status quality of life (QoL) scale. A high score for functional and QoL items/scales from the QLQ-30 represents better function and QOL. A high score in symptoms items from QLQ-30 represents worse symptoms.

    32. Change from baseline in overall scores and individual scales of the EORTC QLQ-CML24 [baseline, 48 weeks after last patient first dose, 96 weeks after last patient first dose]

      The QLQ-CML24 consists of (i) 22 multi-scale items: impact on daily life, symptom burden, impact on worry/mood, satisfaction with care and information, (ii) 2 single items: body image problems, and satisfaction with social life. A higher score on most of the item scales in QLQ-CML24 reflects a larger impairment in the corresponding domain, with the exception of the satisfaction with care and information, and problems and satisfaction with social life, where a higher score reflects a higher level of satisfaction.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Participants eligible for inclusion in this study must meet all of the following criteria:
    1. Male or female patients ≥ 18 years of age.

    2. Participants with CML-CP within 3 months of diagnosis.

    3. Diagnosis of CML-CP (ELN 2020 criteria) with cytogenetic confirmation of Philadelphia chromosome

    • Documented chronic phase CML will meet all the below criteria (Hochhaus et al 2020):

    • < 15% blasts in peripheral blood and bone marrow,

    • < 30% blasts plus promyelocytes in peripheral blood and bone marrow,

    • < 20% basophils in the peripheral blood,

    • Platelet count ≥ 100 x 109/L (≥ 100,000/mm3),

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

    1. Eastern Cooperative Oncology Group (ECOG) performance status of 0,or 1. 5.
    Adequate end organ function as defined by:
    • Total bilirubin < 3 x ULN; patients with Gilbert's syndrome may only be included if total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN

    • Creatinine clearance (CrCl) ≥ 30 mL/min as calculated using Cockcroft-Gault formula,

    • Serum lipase ≤ 1.5 x ULN. For serum lipase > ULN - ≤ 1.5 x ULN, value must be considered not clinically significant and not associated with risk factors for acute pancreatitis 6. Participants must have the following laboratory values within normal limits or corrected to within normal limits with supplements prior to randomization:

    • Potassium (potassium increase of up to 6.0 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min)

    • Total calcium (corrected for serum albumin); (calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with CrCl* ≥ 90 mL/min)

    • Magnesium (magnesium increase of up to 3.0 mg/dL or 1.23 mmol/L if associated with CrCl* ≥ 90 mL/min)

    • For patients with mild to moderate renal impairment (CrCl* ≥ 30 mL/min and <90 mL/min) - potassium, total calcium (corrected for serum albumin) and magnesium should be ≥ LLN or corrected to within normal limits with supplements prior to randomization.

    • *CrCl as calculated using Cockcroft-Gault formula 7. Ability to provide written informed consent prior to any study related screening procedures being performed.

    1. Evidence of typical BCR-ABL1 transcript [e14a2 and/or e13a2] at the time of screening which is amenable to standardized Real time quantitative polymerase chain reaction (RQ-PCR) quantification.
    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. Treatment with either imatinib, or nilotinib, or dasatinib or bosutinib for ≤2 weeks is allowed, but no other treatment with other tyrosine kinase inhibitors prior to randomization is permitted.

    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 within 6 months prior to starting study treatment of myocardial infarction (MI), angina pectoris, coronary artery bypass graft (CABG)

    • 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)

    • QTc ≥ 450 ms (male patients), ≥460 ms (female patients) on the average of three serial baseline ECG (using the QTcF formula) as determined by central reading. If QTcF ≥ 450 ms and electrolytes are not within normal ranges, electrolytes should be corrected and then the patient re-screened for QTc.

    • 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

    1. 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). Please refer to Section 6.3.1

    2. History of significant congenital or acquired bleeding disorder unrelated to cancer.

    3. Major surgery within 4 weeks prior to study entry or who have not recovered from prior surgery.

    4. 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

    5. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis.

    6. History of chronic liver disease leading to severe hepatic impairment, or ongoing acute liver disease.

    Other protocol-defined Inclusion/exclusion criteria will apply.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rocky Mountain Cancer Centers Longmont Colorado United States 80501
    2 Florida Cancer Specialists Dept of Oncology (2) Fort Myers Florida United States 33901
    3 Florida Cancer Specialists Fort Myers Florida United States 33901
    4 Florida Cancer Specialists Panhandle Tallahassee Florida United States 32308
    5 Florida Cancer Specialists West Palm Beach Florida United States 33401
    6 Illinois Cancer Care P.C. IL Cancer Specialists Peoria Illinois United States 61615-7828
    7 University of Kentucky Lexington Kentucky United States 40536
    8 University of Massachusetts Medical Center Dept of Oncology Worcester Massachusetts United States 01655
    9 University of Michigan Clinical Trials Office Ann Arbor Michigan United States 48109
    10 Wake Forest University Baptist Medical Center Comprehensive Cancer Ctr Winston-Salem North Carolina United States 27157
    11 Oncology Hematology Care Inc Cincinnati Ohio United States 45242
    12 Williamette Cancer Center Eugene Oregon United States 97401
    13 Avera Cancer Avera Cancer Institute Sioux Falls South Dakota United States 57105
    14 Chattanooga Oncology and Hematology Associates PC Tennessee Oncology Chattanooga Chattanooga Tennessee United States 37404
    15 Texas Oncology Texas Onc - Amarillo Dallas Texas United States 75246
    16 Texas Oncology-Baylor USO Dallas Texas United States 75246
    17 Texas Oncology P A Austin Dallas Texas United States 75251
    18 University of TX MD Anderson Cancer Center Houston Texas United States 77030
    19 Texas Oncology Northeast Texas Tyler Texas United States 75702
    20 Virginia Cancer Specialists Gainesville Virginia United States 20155
    21 Virginia Oncology Associates Norfolk Virginia United States 23502
    22 Novartis Investigative Site Kingswood New South Wales Australia 2747
    23 Novartis Investigative Site Port Macquarie New South Wales Australia 2444
    24 Novartis Investigative Site Woolloongabba Queensland Australia 4102
    25 Novartis Investigative Site SouthPort Australia 4215
    26 Novartis Investigative Site Linz Upper Austria Austria 4010
    27 Novartis Investigative Site Wien Austria 1090
    28 Novartis Investigative Site Leuven Belgium 3000
    29 Novartis Investigative Site Sofia Bulgaria 1797
    30 Novartis Investigative Site Varna Bulgaria 9010
    31 Novartis Investigative Site Calgary Alberta Canada T2N 4N2
    32 Novartis Investigative Site Hamilton Ontario Canada L8V 1C3
    33 Novartis Investigative Site Ottawa Ontario Canada K1H 8L6
    34 Novartis Investigative Site Toronto Ontario Canada M5G 2M9
    35 Novartis Investigative Site Guangzhou Guangdong China 510515
    36 Novartis Investigative Site Shenzhen Guangdong China 518037
    37 Novartis Investigative Site Zhengzhou Henan China 450008
    38 Novartis Investigative Site Wuhan Hubei China 430022
    39 Novartis Investigative Site Nanjing Jiangsu China
    40 Novartis Investigative Site Nantong Jiangsu China 226000
    41 Novartis Investigative Site Suzhou Jiangsu China 215006
    42 Novartis Investigative Site Xian Shanxi China 710068
    43 Novartis Investigative Site Chengdu Sichuan China 610041
    44 Novartis Investigative Site Tianjin Tianjin China 300020
    45 Novartis Investigative Site Hangzhou Zhejiang China 310003
    46 Novartis Investigative Site Wenzhou Zhejiang China 325000
    47 Novartis Investigative Site Beijing China 100044
    48 Novartis Investigative Site Beijing China 100730
    49 Novartis Investigative Site Lanzhou China
    50 Novartis Investigative Site Shanghai China 200025
    51 Novartis Investigative Site Brno Bohunice Czech Republic Czechia 625 00
    52 Novartis Investigative Site Ostrava Poruba Czech Republic Czechia 708 52
    53 Novartis Investigative Site Hradec Kralove CZE Czechia 500 05
    54 Novartis Investigative Site Aarhus Denmark 8000
    55 Novartis Investigative Site Copenhagen Denmark DK-2100
    56 Novartis Investigative Site Roskilde Denmark 4000
    57 Novartis Investigative Site Helsinki Finland FIN 00290
    58 Novartis Investigative Site Turku Finland 20520
    59 Novartis Investigative Site Bordeaux France 33076
    60 Novartis Investigative Site Lyon Cedex France 69373
    61 Novartis Investigative Site Nantes Cedex 1 France 44093
    62 Novartis Investigative Site Paris Cedex 10 France 75475
    63 Novartis Investigative Site Mannheim Baden-Wuerttemberg Germany 68305
    64 Novartis Investigative Site Aachen Germany 52074
    65 Novartis Investigative Site Berlin Germany 13353
    66 Novartis Investigative Site Frankfurt Germany 60590
    67 Novartis Investigative Site Jena Germany 07740
    68 Novartis Investigative Site Luebeck Germany 23538
    69 Novartis Investigative Site Debrecen Hungary 4032
    70 Novartis Investigative Site Kaposvar Hungary 7400
    71 Novartis Investigative Site Kecskemet Hungary 6001
    72 Novartis Investigative Site Delhi India 110 085
    73 Novartis Investigative Site Petah Tikva Israel
    74 Novartis Investigative Site Ramat Gan Israel 52621
    75 Novartis Investigative Site Tel Aviv Israel 6423906
    76 Novartis Investigative Site Bologna BO Italy 40138
    77 Novartis Investigative Site Milano MI Italy 20122
    78 Novartis Investigative Site Roma RM Italy 00161
    79 Novartis Investigative Site Verona VR Italy 37126
    80 Novartis Investigative Site Nagoya Aichi Japan 453-8511
    81 Novartis Investigative Site Toyoake city Aichi Japan 470 1192
    82 Novartis Investigative Site Kashiwa Chiba Japan 277 8577
    83 Novartis Investigative Site Fukuoka city Fukuoka Japan 812-8582
    84 Novartis Investigative Site Fukushima city Fukushima Japan 960 1295
    85 Novartis Investigative Site Sapporo city Hokkaido Japan 060 8648
    86 Novartis Investigative Site Kobe-city Hyogo Japan 650-0047
    87 Novartis Investigative Site Kurashiki-city Okayama Japan 710-8602
    88 Novartis Investigative Site Osaka Sayama Osaka Japan 589 8511
    89 Novartis Investigative Site Suita city Osaka Japan 565 0871
    90 Novartis Investigative Site Sunto Gun Shizuoka Japan 411 8777
    91 Novartis Investigative Site Shimotsuke Tochigi Japan 329-0498
    92 Novartis Investigative Site Chuo-city Yamanashi Japan 409-3898
    93 Novartis Investigative Site Akita Japan 010-8543
    94 Novartis Investigative Site Osaka Japan 545-8586
    95 Novartis Investigative Site Yamagata Japan 990 9585
    96 Novartis Investigative Site Uijeongbu si Gyeonggi Do Korea, Republic of 11759
    97 Novartis Investigative Site Seoul Seocho Gu Korea, Republic of 06591
    98 Novartis Investigative Site Seoul Korea, Republic of 03080
    99 Novartis Investigative Site Seoul Korea, Republic of 03722
    100 Novartis Investigative Site Seoul Korea, Republic of 06351
    101 Novartis Investigative Site Kuantan Pahang Malaysia 25100
    102 Novartis Investigative Site Subang Jaya Selangor Malaysia 47500
    103 Novartis Investigative Site Pulau Pinang Malaysia 10990
    104 Novartis Investigative Site Selangor Malaysia 68000
    105 Novartis Investigative Site Bergen Norway 5021
    106 Novartis Investigative Site Oslo Norway 0372
    107 Novartis Investigative Site Trondheim Norway 7006
    108 Novartis Investigative Site Porto Portugal 4200-072
    109 Novartis Investigative Site Vila Nova de Gaia Portugal 4434 502
    110 Novartis Investigative Site Moscow Russian Federation 127644
    111 Novartis Investigative Site Saint Petersburg Russian Federation 191024
    112 Novartis Investigative Site Singapore Singapore 119228
    113 Novartis Investigative Site Singapore Singapore 169608
    114 Novartis Investigative Site Bratislava Slovak Republic Slovakia 83310
    115 Novartis Investigative Site Kosice Slovak Republic Slovakia 040 66
    116 Novartis Investigative Site Granada Andalucia Spain 18014
    117 Novartis Investigative Site Barcelona Catalunya Spain 08036
    118 Novartis Investigative Site El Palmar Murcia Spain 30120
    119 Novartis Investigative Site Pamplona Navarra Spain 31008
    120 Novartis Investigative Site Madrid Spain 28046
    121 Novartis Investigative Site Goteborg Sweden 413 45
    122 Novartis Investigative Site Lund Sweden 221 85
    123 Novartis Investigative Site Stockholm Sweden 141 86
    124 Novartis Investigative Site Bellinzona Switzerland 6850
    125 Novartis Investigative Site Zürich Switzerland 8091
    126 Novartis Investigative Site Taichung Taiwan 40447
    127 Novartis Investigative Site London United Kingdom W12 0NN
    128 Novartis Investigative Site Nottingham United Kingdom NG5
    129 Novartis Investigative Site Oxford United Kingdom OX3 7LJ

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT04971226
    Other Study ID Numbers:
    • CABL001J12301
    • 2021-000678-27
    First Posted:
    Jul 21, 2021
    Last Update Posted:
    Aug 3, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Novartis Pharmaceuticals
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 3, 2022