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JOURNAL ONKOLOGIE – STUDIE
ASC4START

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)

Rekrutierend

NCT-Nummer:
NCT05456191

Studienbeginn:
November 2022

Letztes Update:
13.03.2024

Wirkstoff:
Asciminib, Nilotinib

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Philadelphia Chromosome

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 3

Sponsor:
Novartis Pharmaceuticals

Collaborator:
-

Studienleiter

Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Kontakt

Studienlocations
(3 von 132)

Novartis Investigative Site
68305 Mannheim
(Baden-Württemberg)
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Novartis Investigative Site
81241 Muenchen
(Bayern)
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Novartis Investigative Site
42551 Velbert
(Nordrhein-Westfalen)
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Novartis Investigative Site
01307 Dresden
(Sachsen)
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Novartis Investigative Site
86179 Augsburg
(Bayern)
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Novartis Investigative Site
15526 Bad Saarow
(Brandenburg)
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Novartis Investigative Site
95445 Bayreuth
(Bayern)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
13353 Berlin
(Berlin)
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Novartis Investigative Site
53105 Bonn
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
28177 Bremen
(Bremen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
09113 Chemnitz
(Sachsen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
91054 Erlangen
(Bayern)
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Novartis Investigative Site
45147 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
60590 Frankfurt
(Hessen)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
79106 Freiburg
(Baden-Württemberg)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
06120 Halle S
(Sachsen-Anhalt)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
20246 Hamburg
(Hamburg)
GermanyRekrutierend» Google-Maps
Novartis Investigative Site
30161 Hannover
(Niedersachsen)
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Novartis Investigative Site
69120 Heidelberg
(Baden-Württemberg)
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Novartis Investigative Site
07740 Jena
(Thüringen)
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Novartis Investigative Site
04103 Leipzig
(Sachsen)
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Novartis Investigative Site
23538 Luebeck
(Schleswig-Holstein)
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Novartis Investigative Site
39104 Magdeburg
(Sachsen-Anhalt)
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Novartis Investigative Site
35039 Marburg
(Hessen)
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Novartis Investigative Site
80377 Muenchen
(Bayern)
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Novartis Investigative Site
33098 Paderborn
(Nordrhein-Westfalen)
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Novartis Investigative Site
93049 Regensburg
(Bayern)
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Novartis Investigative Site
72076 Tuebingen
(Baden-Württemberg)
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Novartis Investigative Site
89081 Ulm
(Baden-Württemberg)
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Novartis Investigative Site
97080 Wuerzburg
(Bayern)
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Arizona Oncology Associates .
85016 Phoenix
United StatesRekrutierend» Google-Maps
Florida Cancer Specialists Dept of Oncology (2)
33901 Fort Myers
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Kelly Whitehead
Phone: +1 727 216 1143
E-Mail: kelly.whitehead@flcancer.com» Ansprechpartner anzeigen
Minnesota Oncology Hematology P A Minnesota Oncology Hematology
55404 Minneapolis
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Brianna Lennox
Phone: 612-884-6300
E-Mail: Brianna.Lenox@usoncology.com» Ansprechpartner anzeigen
Regions Hospital Oncology Research Consortium
55101 Saint Paul
United StatesRekrutierend» Google-Maps
Sarah Cannon Research Institute HCA Healthcare Research Inst
37203 Nashville
United StatesRekrutierend» Google-Maps
Ansprechpartner:
Vanesa Veletanlic
Phone: 615-515-1900
E-Mail: Vanesa.Veletanlic@SCRI.com» Ansprechpartner anzeigen
Texas Oncology PA Bedford
76022 Bedford
United StatesRekrutierend» Google-Maps
Novartis Investigative Site
C1181ACH Caba
ArgentinaRekrutierend» Google-Maps
Novartis Investigative Site
C1221ADH Caba
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Novartis Investigative Site
C1039AAC Buenos aires
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Novartis Investigative Site
C1114AAN Buenos Aires
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Novartis Investigative Site
C1425AUM Buenos Aires
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Novartis Investigative Site
M5G 2M9 Toronto
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Novartis Investigative Site
625 00 Brno Bohunice
CzechiaRekrutierend» Google-Maps
Novartis Investigative Site
128 20 Praha 2
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Novartis Investigative Site
30599 Plzen-Bory
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Novartis Investigative Site
100 34 Praha 10
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Novartis Investigative Site
14033 Caen Cedex
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Novartis Investigative Site
63003 Clermont Ferrand
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Novartis Investigative Site
13273 Marseille
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Novartis Investigative Site
44093 Nantes Cedex 1
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Novartis Investigative Site
67200 Strasbourg
FranceRekrutierend» Google-Maps
Novartis Investigative Site
54511 Vandoeuvre les Nancy cedex
FranceRekrutierend» Google-Maps
Novartis Investigative Site
455 00 Ioannina
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Novartis Investigative Site
570 10 Thessaloniki
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Novartis Investigative Site
380009 Ahmedabad
IndiaRekrutierend» Google-Maps
Novartis Investigative Site
249203 Rishikesh
IndiaRekrutierend» Google-Maps
Novartis Investigative Site
110029 New Delhi
IndiaRekrutierend» Google-Maps
Novartis Investigative Site
13620 Bundang Gu
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
11759 Uijeongbu si
Korea, Republic ofRekrutierend» Google-Maps
Novartis Investigative Site
05460 Alor Setar
MalaysiaRekrutierend» Google-Maps
Novartis Investigative Site
93586 Kuching
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Novartis Investigative Site
46150 Petaling Jaya
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Novartis Investigative Site
59100 Kuala Lumpur
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Novartis Investigative Site
3318AT Dordrecht
NetherlandsRekrutierend» Google-Maps
Novartis Investigative Site
022328 Bucharest
RomaniaRekrutierend» Google-Maps
Novartis Investigative Site
540136 Tg Mures
RomaniaRekrutierend» Google-Maps
Novartis Investigative Site
030 171 Bucharest
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Novartis Investigative Site
021494 Bucuresti
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Novartis Investigative Site
400124 Cluj-Napoca
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Novartis Investigative Site
200136 Craiova
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Novartis Investigative Site
300079 Timisoara
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Novartis Investigative Site
119228 Singapore
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Novartis Investigative Site
169608 Singapore
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Novartis Investigative Site
S308433 Singapore
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Novartis Investigative Site
040 66 Kosice
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Novartis Investigative Site
85107 Bratislava
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Novartis Investigative Site
2013 Soweto
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Novartis Investigative Site
0044 Pretoria
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Novartis Investigative Site
1211 Genève
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Novartis Investigative Site
Abu Dhabi
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Novartis Investigative Site
TR1 3LJ Truro
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Novartis Investigative Site
G12 0YN Glasgow
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Novartis Investigative Site
GL1 3NN Gloucester
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Novartis Investigative Site
NP9 2UB Gwent
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Novartis Investigative Site
SE5 9RS London
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Novartis Investigative Site
W12 0HS London
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Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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. **Pseudohyperkaliemia in

case of thrombocytosis is not an exclusion criterion.

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 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.

Studien-Rationale

Primary outcome:

1. Time to discontinuation of study treatment due to adverse event (TTDAE). (Time Frame - From date of first dose to date of treatment discontinuation due to AE, assessed up to 4.5 years):
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:

1. Percentage of participants with Major Molecular response (MMR) at scheduled data collection time points (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.):
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.

2. Percentage of participants with Major Molecular response (MMR) by scheduled data collection time points (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.):
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.

3. Percentage of participants with MR4.0 at scheduled data collection time points (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.):
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.

4. Percentage of participants with MR4.0 by scheduled data collection time points (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):
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

5. Percentage of participants with MR4.5 at scheduled data collection time points (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.):
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.

6. Percentage of participants with MR4.5 by scheduled data collection time points (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.):
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

7. Percentage of participants with Complete Hematological response (CHR) at scheduled data collection time points (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.):
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.

8. Percentage of participants with Complete Hematological response (CHR) by scheduled data collection time points (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.):
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

9. Percentage of participants with BCR::ABL1 ratio ≤1% by Week 48 and Week 96. (Time Frame - 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

10. Duration of MMR (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.):
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.

11. Duration of MR4.0 (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.):
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

12. Duration of MR4.5 (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.):
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.

13. Time to first MMR (Time Frame - From the date of randomization to the date of the first MMR, assessed up to approximately 4.5 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.

14. Time to first MR4.0 (Time Frame - From the date of randomization to the date of the first MR4, assessed up to approximately 4.5 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.

15. Time to first MR4.5 (Time Frame - From the date of randomization to the date of the first MR4.5, assessed up to approximately 4.5 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.

16. Time to treatment failure (TTF). (Time Frame - Up to approximately 4.5 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 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

17. Event free survival (EFS) (Time Frame - Up to approximately 4.5 years.):
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.

18. Progression free survival (PFS). (Time Frame - Up to approximately 4.5 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.

19. Overall survival (OS). (Time Frame - Up to approximately 4.5 years.):
OS is defined as the time from the date of randomization to the date of death from any cause.

20. Time to treatment discontinuation (TTD) due to selected reasons (Time Frame - Up to approximately 4.5 years):
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

21. 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) (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.):
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.

22. Change from baseline in overall scores and individual scales of the European organization for research and treatment of cancer CML module (EORTC QLQ-CML24) (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.):
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.

Studien-Arme

  • Experimental: Asciminib
    Participants will receive asciminib 80 mg QD
  • Active Comparator: Nilotinib
    Participants will receive nilotinib 300 mg BID

Geprüfte Regime

  • Asciminib (ABL001):
    Asciminib 80 mg QD administered under fasting conditions.
  • Nilotinib:
    Nilotinib 300 mg BID administered under fasting conditions.

Quelle: ClinicalTrials.gov


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"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)"

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