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Trial details
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Current status:
Approved
|
Date registered:
21/11/2023
Trial version(s)
History: 06/05/2022
History: 06/05/2022
History: 06/05/2022
History: 06/05/2022
History: 06/05/2022
Current: 06/05/2022
Click here to view the tips and fields' descriptions
Main Information
Primary registry identifying number
LBCTR2022055038
Protocol number
CABL001A2001B
MOH registration number
Trial already registered with the MoPH
Study registered at the country of origin
Type of registration
Prospective
Date of registration in national regulatory agency
Primary sponsor
Novartis Pharmaceuticals
Primary sponsor: Country of origin
Novartis Pharmaceuticals
Public title
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Acronym
Asciminib Roll-over Study
Scientific title
An Open Label, Multi-center Asciminib Roll-over Study to Assess Long-term Safety in Patients Who Have Completed a Novartis Sponsored Asciminib Study and Are Judged by the Investigator to Benefit From Continued Treatment
Acronym
Brief summary of the study: English
This is a long term safety study for patients who have completed a Novartis sponsored asciminib study and are judged by the investigator to benefit from continued treatment
Brief summary of the study: Arabic
دراسة تمديد لدى مرضى أنجزوا دراسة حول أسكيمينيب برعاية نوفارتيس وبحسب تقدير الباحث يستفيدون من مواصلة العلاج
Health conditions/problem studied: Specify
Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia
Interventions: Specify
- Drug: Asciminib single agent Taken orally, twice daily (BID) or once daily (QD), in fasting state Other Name: ABL001 - Drug: Asciminib Taken orally, once daily, in the morning with low-fat meal or twice daily in fasting state Other Name: ABL001 - Drug: Imatinib Taken orally, once daily, in the morning with low-fat meal Other Name: STI571 - Drug: Nilotinib Taken orally, twice daily, on an empty stomach Other Name: AMN107 - Drug: Bosutinib Taken orally, once daily, with food - Drug: Dasatinib Taken orally, once daily in a fasted state, 1 or 2 hours before a meal Other Name: Sprycel
Key inclusion and exclusion criteria: Inclusion criteria
1- Participant with PH+ CML or PH+ ALL currently receiving treatment with asciminib (single agent or in combination with imatinib, nilotinib or dasatinib), imatinib, nilotinib or bosutinib alone within a Novartis-sponsored study and, in the opinion of the Investigator, would benefit from continued treatment. 2- Participant has demonstrated compliance on the parent study protocol and is willing and able to comply with scheduled visits, treatment plans and any other study procedures.
Key inclusion and exclusion criteria: Gender
Both
Key inclusion and exclusion criteria: Age minimum
18
Key inclusion and exclusion criteria: Age maximum
99
Key inclusion and exclusion criteria: Exclusion criteria
1- Participant has been discontinued from parent study treatment. 2- Participant currently has unresolved toxicities reported as possibly related to study treatment in the parent study. 3- Participant's ongoing treatment is currently approved and reimbursed at country level. 4- Pregnant or nursing (lactating) women. 5- Women of child-bearing potential, unless they are using highly effective methods of contraception and willing to continue while taking study treatment. 6- Sexually active males receiving imatinib, nilotinib, bosutinib or dasatinib unwilling to follow the relevant contraception requirements in the local prescribing information. 7- Applicable only for participants on bosutinib treatment that switch to asciminib treatment at enrollment: - Asymptomatic pancreatitis - abnormal ECG - any grade 3 or 4 toxicity not resolved to grade 2 or lower within 28 days before starting asciminib treatment
Type of Study
Type
Interventional
Type of intervention
Pharmaceutical
Trial scope
Safety
Trial scope: Specify scope
Study design: Allocation
Non-randomized controlled trial
Study design: Masking
Open (masking not used)
Study design: Control
Uncontrolled
Study phase
4
Study design: Purpose
Treatment
Study design: Assignment
Parallel
IMP has market authorization
No
Name of IMP
Asciminib
Type of IMP
Cell therapy
Pharmaceutical class
orally bioavailable specific BCR-ABL inhibitor with a novel mechanism of action
Therapeutic indication
Chronic Myelogenous Leukemia Acute Lymphoblastic Leukemia
Therapeutic benefit
increase OS & PFS
Biospecimen retention
None retained
Biospecimen description
N/A
Target sample size
1
Actual enrollment target size
1
Date of first enrollment: Type
Actual
Date of first enrollment: Date
11/10/2022
Date of study closure: Type
Actual
Date of study closure: Date
29/10/2027
Recruitment status
Complete
Date of completion
11/10/2022
IPD sharing statement plan
Yes
IPD sharing statement 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
Additional data URL
https://clinicaltrials.gov/ct2/show/record/NCT04877522?term=CABL001A2001B&draw=2&rank=1
Summary Results
Secondary Identifying Numbers
Full name of issuing authority
Secondary identifying number
clinicaltrials.gov
NCT04877522
Sources of Monetary or Material Support
Name
Novartis Pharmaceuticals
Secondary Sponsors
Name
N/A
Contact for Public/Scientific Queries
Contact type
First name
Last name
Address
Country
Telephone
Email
Affiliation
Public
Ali
Bazarbachi
Beirut
Lebanon
+961 3 612434
bazarbac@aub.edu.lb
American University of Beirut Medical Center
Scientific
Hind
Khairallah
Beirut
Lebanon
+961 1 512002 Ext. 271
Hind.Khairallah@ fattal.com.lb
Khalil Fattal et Fils s.a.l.
Centers/Hospitals Involved in the Study
Center/Hospital name
Name of principles investigator
Principles investigator speciality
Ethical approval
American University of Beirut Medical Center
Ali Bazarbachi
Hematology Oncology
Approved
Ethics Review
Ethics approval obtained
Approval date
Contact name
Contact email
Contact phone
American University of Beirut Medical Center
03/05/2022
Fuad Ziyadeh
fz05@aub.edu.lb
+961 1 350000 ext:5445
Countries of Recruitment
Name
Lebanon
Germany
Italy
Japan
Republic of Korea
Mexico
Portugal
Russian Federation
Spain
Turkey
United Kingdom
United States of America
Health Conditions or Problems Studied
Condition
Code
Keyword
Chronic Myelogenous Leukemia
Leukaemia, unspecified (C95.9)
CML
Acute Lymphoblastic Leukemia
Leukaemia, unspecified (C95.9)
ALL
Interventions
Intervention
Description
Keyword
Consenting, IMP administration
Consenting, IMP administration
Consenting, IMP administration
Primary Outcomes
Name
Time points
Measure
Number of participabts with adverse events (AEs) and serious adverse events (SAEs)
5 years
All AEs and SAEs will be tabulated and listed for participants in the Safety Set by treatment group. From day of first administration of study treatment to 30 days after the last study treatment.
Key Secondary Outcomes
Name
Time points
Measure
Percentage of participants with clinical benefit as assessed by Investigator
5 years
Investigators' assessment of clinical benefit will collected through the Investigator confirming that the patient is still benefiting from treatment. This will be evaluated and tabulated for participants in the Safety Set by treatment group at each visit.
Trial Results
Summary results in Lebanon
Study results globally
Date of posting of results summaries
Date of first journal publication of results
Results URL link
Baseline characteristics
Participant flow
Adverse events
Outcome measures
URL to protocol files
Link(s) to publications related to the study
Changes History
Change
Date
Annual Review 2023
24/10/2023
ABL001 IB Edition 10
24/10/2023
ABL001 SUSARs 01Apr2023-30Sep2023
24/10/2023
Download as PDF
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